Search Results

The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.

The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device: - Scissor like design for opening and closing the instrument jaws and activating RF energy. . The mechanism must be held in the closed position during vessel sealing and cutting. - . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application. - . A trigger for actuating the blade. All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator. The instrument is compatible with the Covidien ForceTriad Energy Platform and Valleylab FT10 Energy Platform. The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (K220411) and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device: - Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting. - An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application. - A trigger for actuating the blade. All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator. The instrument is compatible with the Covidien ForceTriad Enerqy Platform and Valleylab FT10 Energy Platform. The scope of the submission only includes the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.

Not Found

The Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Vein360 Endovenous RFA Catheter is a reprocessed single-use device (SUD) consisting of a molded handle with actuation switch, an integrated instrument cable, and a flexible catheter shaft with a radiofrequency (RF) heating element at the distal end. The catheter and integrated connection cable are provided sterile and meant for single patient use. The catheter's function is to provide thermal energy to the desired treatment site via RF heating of the heating element and to relay temperature back to the RF generator. The Vein360 Endovenous RFA Catheter is subjected to reprocessing operations following the initial clinical use of the OEM predicate. These operations include cleaning, inspection, packaging and sterilization. After reprocessing, the Vein360 reprocessed Endovenous RFA Catheter retains substantially equivalent performance to that of the OEM predicate. The Vein360 reprocessed Endovenous RFA Catheter is reprocessed one (1) time.

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Covidien™ LigaSure™ 5 mm Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744) is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The outer diameter of the instrument shaft is 5 mm with a working length of 23 cm, 37 cm, or 44 cm.

The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The Reprocessed LigaSure Sealer/ Divider can be used on yessels (arteries, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LF4418 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the instrument handle: - A lever for opening and closing the instrument iaws. The mechanism incorporates a latch to . hold the jaws in the closed position during vessel sealing and cutting. - . An activation button for generator power to initiate vessel sealing. - A triager for actuating the cutter. ● - . A knob to rotate the instrument jaws. All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attaches to the compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator. For the LF4418, the Original Manufacturer applies a non-stick coating to the jaws of the device to reduce tissue sticking. When reprocessing the LF4418, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device. The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are used to power the device or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generator or footswitch.

The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including: - Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.

The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.