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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 Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The ForceTriad™ is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The generator is intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired. The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed. including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. This 510(k) only applies to the LigaSure™ Vessel sealing portion of the generator. The generator is electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power. The generator is used with a selection of instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete. No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.

The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading.

The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.

The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.