Simple Pneumoperitoneum Needle,Single Endo Use Clip Applier Suppliers & Manufacturers

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Simple Pneumoperitoneum Needle (FDA Code: FHP / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Autosuture, Elmed Inc., Ethicon, Inc., more...

Single Endo Use Clip Applier
Kroslak Enterprises, Inc.

Single Lumen Tube for Intestinal Decompression (FDA Code: FEF / 876.598)

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

Teleflex Medical

Single Needle Dialysis Kit (FDA Code: LBW / 876.554)

Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Classification. (1) Class III (premarket approval) for the implanted blood access device.

Angiodynamics, Inc.

Single Pass Dialysate Delivery System (FDA Code: FIL / 876.582)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

Fresenius Medical Care North America, Erika De Reynosa, S.A. De C.V.

Single Patient Dialysate Delivery System (FDA Code: FKP / 876.582)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

B. Braun Medical Inc., Medi/Nuclear Corp., Inc., G.E.M. Water Systems, Int'l., LLC, more...

Single use VacutainerT Needle Holder
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Single-Needle Hemodialysis Catheter
Angiodynamics, Inc., Medisystems Corp, Vas-Cath, Inc.

Single-Pass Hemodialysis Unit Converter
Instrumentarium Corp.

Single-Use Needle Holder
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Single-Use Peritoneal Dialysis Catheter (FDA Code: FKO / 876.563)

Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

Classification. Class II (performance standards).

Autosuture, R-Group International, Vyaire Medical, Inc., more...

Slings and Anchor Systems
Cook Urological, American Medical Systems, C. r. Bard, Inc., more...

Small Pediatric Urethral Catheters
Rusch Inc., Alsius Corporation, Cook Urological, more...

Small-diameter Semirigid Ureteroscopes
Gyrus ACMI

Soft Elastic Intestinal Clamps
Codman & Shurtleff, Inc., Herger AG, Seven Eight & Co, more...

Sorbent Hemoperfusion System (FDA Code: FLD / 876.587)

Identification. A sorbent hemoperfusion system is a device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (876.5820) and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.

Classification. Class III (premarket approval).

Aethlon Medical, Inc., Gambro, American Health Care Systems, Inc., more...

Sorbent Regenerated Dialysate Delivery System (FDA Code: FKT / 876.56)

Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

Classification. Class II (performance standards).

Sorb Technology, Inc.

Specimen Forceps
Cimex International, Kampala Surgical Pvt Ltd, Rsamti Impex, more...

Sperm Collection Electrical Stimulator (FDA Code: LNL)
Irvine Scientific, G & S Instrument Co.

Sphincteroscope (FDA Code: FDR / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Luxtec, Surgical Tools, Inc., Seven Eight & Co, more...

Spiral Reinforced Urethral Stent
Cook Urological

Standard Flow Resectoscopes
Standard Flow Resectoscopes treats enlarged prostate glands, removes bladder tumors and incises strictures in the urinary tract.
Gyrus ACMI, Stryker, Scholly Fiberoptic GmbH.

Standard Needle Holders
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Standard Needle Suspension
Cook Urological, Medical Plastic Devices (MPD) Inc.

Standard Resection Electrodes
Gyrus ACMI, C. r. Bard, Inc., Gyrus Group PLC, more...

Standard Urethral Access
Cook Urological, Vomed Volzer Medizintechnik GmbH & Co. KG

Static Urodynamics System
Neomedix Systems

Stent Positioners With Radiopaque Band
Stent Positioners With Radiopaque Band is used for retrograde positioning of a ureteral stent. The radiopaque band improves fluoroscopic visibility of the positioner tip.
Motion Medical Distributing

Steppers and Stabilizers
North American Scientific, Inc., CMS, Inc., C. r. Bard, Inc., more...

Sterile Closed Urine Drainage System for Nonindwelling Catheter (FDA Code: EYZ / 876.525)

Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

Mentor Corporation, Autosuture, Hospira, Inc., more...

Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT / 876.525)

Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

Cook Urological, Rece International Corp., Valentine International Limited

Sterile Infant Gavage Set (FDA Code: FHT / 876.598)

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

Smiths Medical Deutschland GmbH, AS Advanced Medical Systems GmbH

Sterile Irrigation Tray (FDA Code: EYN / 876.598)

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

Covidien, Stryker, MedexSupply, more...

Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ / 876.525)

Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

Autosuture, Southwest Medicals LLC, GKR Industries, Inc., more...

Sterile Midstream Catch Kits
Sterile MidStream Catch Kits includes things for cleaning catch urine specimen collection. Each sterile wrapped tray has a 4 oz urine cup with tab ring & screw cap, bilingual instruction pamphlet and ID label. Each specimen container is calibrated in 10 cc & .25-ounce increments up to 120 ccs.
Covidien

Sterile Obturators
Gyrus ACMI, Medit Inc

Sterile Paste-On Incontinence Device (FDA Code: EXI / 876.525)

Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

Hollister Incorporated, Amsino International, Inc, Bioderm, Inc., more...

Sterile Urethral Catheterization Kit (FDA Code: FCM / 876.513)

Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Classification. (1) Class II (performance standards).

Autosuture, Hollister Incorporated, Covidien, more...

Stirrup (FDA Code: EYD / 876.489)

Identification. A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.

Classification. (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 876.9.

Rycor Medical, Inc., Allen Medical Systems, MedexSupply, more...

Stomach and Intestinal Suture Apparatus (FDA Code: FHM / 878.48)

Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Autosuture, Ethicon, Inc., Aesculap Inc., more...

Stomach and Intestinal Suture Clip
Gebrüder Martin GmbH & Co. KG,

Stomach Evacuator Tube
Vygon S.A. Spain, Vygon S A, Benlan Inc., more...

Stomach pH Electrode (FDA Code: FFT / 876.14)

Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Adinstruments, Inc, Medtronic Xomed Surgical Products, Inc, Given Imaging Inc., more...

Stone Extractors
Stone Extractors are used for stone manipulation and removal in the renal pelvis under direct vision.
Rusch Inc., Cook Urological, Gyrus ACMI, more...

Stone Grasping Forceps
Rusch Inc., Autosuture, High Class Dental, more...

Stone Manipulation Forceps
Elmed Inc., Cook Group Incorporated, Codman & Shurtleff, Inc., more...

Stone Manipulation, Stone Extractors
Rusch Inc., Autosuture, Cook Urological, more...

Stone Retrieval Baskets
Stone Retrieval Baskets is used to retrieve gall stones and kidney stones.
Vitae Core, Millennium Biotech, Nidhi Meditech Systems, more...

Straight Tip Catheter
Straight tip catheter reduces the risk of urinary tract infections through its unique introducer tip. It is made up of softer, flexible material like red rubber, which is softer than plastic. It provides maximum comfort upon insertion through ultra smooth catheter eyelets that are formed with advanced ultrasonic technology.
Cardinal Health, Inc.

Suction Biopsy Instrument (FDA Code: FCK / 876.1075)

Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Cook Group Incorporated, PMT Corporation, Ethicon, Inc., more...

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