Profile: Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO 9001, ISO 9002, CE MARK certified company. We offer products like endo catchT 10mm specimen bag, endo catchT II 15mm specimen bag, LDST powered 15W single use stapler, LDST 15W single use loading unit & ProTackT 5mm single use instrument. Our Autosuture™ Endo Clip™ MultApplier™ reusable clip applier is designed for use with the endo Clip™ MultApplier™ single-use loading unit, each of which contains eight titanium clips.
The company has revenues of > USD 1 Billion, has ~5780 employees and is ISO 9001, ISO 9002, CE certified.
• Reusable Suture Needle (FDA Code: GDL / 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. |
• Right Handed Mayo Scissors |
• Ring Forceps |
• Roticulating Staplers |
• Roticulating Staplers with Absorbable Staples |
• Roticulating Staplers with Titanium Staples |
• Roticulating Staplers, Single Use Instrument |
• Rustproof Intraocular Forceps |
• Scalp Circular Electrode and Applicator (FDA Code: HGP / 884.2675) A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes. |
• Scalpel Blade (FDA Code: GES / 878.4800) |
• Scissors |
• Self Adhesive Strips (FDA Code: FPX / 880.5240) |
• Self Centering Bone Holding Forceps |
• Self Retaining Cervical Retractors |
• Self-Opening Iris Scissors |
• Semi Rigid biopsy forceps |
• Serrated Jaw Intraocular Forceps |
• Short Trocar |
• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200) An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. |
• Shoulder Repair Rasps |
• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030) Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. |
• Simple Pneumoperitoneum Needle (FDA Code: FHP / 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. |
• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. |
• Single use Aortic Punch |
• Single Use Laparoscopic Retractors |
• Single Use Self Retaining Lighted Retractor System |
• Single Use Specimen Pouch |
• Single Use Trocars With Conductive Sleeves |
• Single Use Trocars With Non-conductive Sleeves |
• Single-Use Peritoneal Dialysis Catheter (FDA Code: FKO / 876.5630) (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. |
• Skin Closure Adhesive Strips (FDA Code: FPX / 880.5240) |
• Skin Closures |
• Skin Closures, Knee Braces |
• Skin Closures, Passive Closure Devices |
• Skin Closures, Skin Staplers |
• Skin Machines |
• Skin Machines, "Quigong" Machine |
• Skin Machines, Micro Epidermal Skin Resurfacing System |
• Skin Marker (FDA Code: FZZ / 878.4660) A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. |
• Skin Staplers |
• Skin Staplers & Removers |
• Skin Staplers with Stainless Steel Staples) |
• Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Specimen Collection Device (FDA Code: LIO / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms. |
• Spinal Fluid Manometer (FDA Code: FMJ / 880.2500) A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid. |
• Stainless Steel Cilia Forceps |
• Stainless Steel Iris Scissors |
• Stainless Steel Mayo Scissors |
• Stainless Steel Needle Holders |