US Endoscopy Group

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Contact: Jim Sarosy - International Sales Manager
Web: http://www.usendoscopy.com
E-Mail:
Address: 5976 Heisley Road, Mentor, Ohio 44060, USA
Phone: +1-(440)-639-4494, 800-769-8226 | Fax: +1-(440)-639-4495 | Map/Directions >>

Profile: US Endoscopy Group specializes in the design and manufacture of accessories for GI endoscopy. The BioShield® biopsy valves & irrigation accessories are used for single-use & offer protection for patients and staff. Our disposable bite blocks and coordinating straps are latex-free & reduce the risk of severe allergic reaction. The capsule endoscope delivery device places video capsules into the stomach or small intestine, for surveillance of patients with oropharyngeal or mechanical dysphagia, and gastroparesis. Our Carr-Locke injection needle is designed to operate the articulated conditions, including side-viewing duodenoscopes. The laparoscopic product line includes the Endo-Sock™ retrieval pouch, aspiration needles and cholangiography systems.

The company was founded in 1991, has revenues of USD 10-25 Million, has ~200 employees and is ISO 13485 certified.

FDA Registration Number: 1528319

36 Products/Services (Click for related suppliers)

• Biopsy Forceps

• Biopsy Instruments (FDA Code: KNW / 876.1075)

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.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Bite Block (FDA Code: JXL / 882.5070)

A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

• Catheter Cannula (FDA Code: DQR / 870.1300)

A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

• Cholangiography Catheters (FDA Code: GBZ / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

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.

• Electric Biopsy Forceps (FDA Code: KGE / 876.4300)

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Endoscope Accessories (FDA Code: KOG)

• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 876.1500)

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.

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

• Endoscopic Cleaning Accessories (FDA Code: FEB / 876.1500)

• Endoscopic Cytology Brush (FDA Code: FDX / 876.1500)

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300)

• Endoscopic Irrigation/Suction System (FDA Code: OCX / 876.1500)

• Endoscopic Non-Manual Air Pump (FDA Code: FEQ / 876.1500)

• Endoscopic Snare

• Endoscopy, Flexible Biopsy Forceps

• Flexible Snare (FDA Code: FDI / 876.4300)

• Flexible Stone Dislodger (FDA Code: FGO / 876.4680)

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500)

• Gastro-Urology Evacuator (FDA Code: KQT / 876.4370)

A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

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).

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• Injection Needle

• Medical Probes (FDA Code: HXB / 888.4540)

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075)

• Non-Electrical Snare (FDA Code: FGX / 876.4730)

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Operating-Room Table and Attachments (FDA Code: BWN / 878.4950)

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Probes (FDA Code: HXB / 888.4540)

• Reusable Biopsy Forceps

• Suction Biopsy Instrument (FDA Code: FCK / 876.1075)

• Surgical Table Cushion (FDA Code: LWG / 878.4950)

• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740)

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Wireless Gastrointestinal Imaging System, Capsule (FDA Code: NEZ / 876.1300)

An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.