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V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 180 absorbable wound closure device (Size 4-0) is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.

The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Autosuture™ Endo GIA™ Stapler as described in the predicate submission K083519. The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue. The black Reloads shall be made available in 45 mm and 60 mm lengths.

V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.

V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.

The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.

The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.

COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

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Over the counter use as a primary dressing around drains, IV sites, and tracheotomies.

The Kendall Antimicrobial Drain Dressing for OTC use is a sterile, single use wound dressing consisting of a rayon/polyester nonwoven material treated with polyhexamethylene biguanide hydrochloride (0.2%), and is available in sponge form.