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REVOLVE ENVI™ 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE ENVI™ 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040. Suction Lipoplasty System. and assigned product code MUU. The subject device should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe. The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system: - Canister (including mesh filter) - Syringe Adapter - Temperature Strip - Lactated Ringer's Tubing Set - Vacuum Tubing Set The device is offered in a single size, is packaged in a thermoformed tray and Tyvek® lidding and is sterilized via gamma irradiation. The device is a single-use device to be used in a healthcare facility.

REVOLVE™ ENVI 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ ENVI 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrontestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Revolve Envi 600 System consists of a sterile, single use canister and accessories intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040, Suction Lipoplasty System, and assigned product code MUU. The subject device is intended to be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is collected from the patient using liposuction tubing and cannula that are supplied by the user or the institution. This tissue is harvested inside the canister which contains a 600ml inner basket with 200um mesh filter. A manual stirring assembly allows the user to mix the tissue and fluids during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe. For user convenience, the device is supplied with the following accessories designed for use with the Revolve Envi 600 System: - . Luer extraction tip - . Toomey and catheter syringe extraction tip - . Toomey/Catheter tip syringe to Luer syringe adapter - . Temperature strip - . Lactated Ringer's tubing set - . Suction tubing set. The device is offered in a single size, is packaged in a thermoformed tray and lid with Tyvek® lidding, and is sterilized via gamma irradiation. The device is a single use device to be used in a healthcare facility.

ARTIA Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement in plastic and reconstructive surgery. ARTIA Tissue Matrix is intended for single patient, one time use only.

ARTIA Reconstructive Tissue Matrix Perforated (ARTIA Tissue Matrix Perforated) is a surgical mesh that is derived from porcine dermis and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. ARTIA Tissue Matrix Perforated is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold for cellular and microvascular ingrowth. ARTIA Tissue Matrix Perforated consists of a terminally sterilized sheet of processed porcine dermal matrix provided in various geometric configurations and packaged in a plastic holder enclosed within a pouch. The device is sterilized via electron beam irradiation. The subject device has the same underlying scientific technology, principles of operation, Intended Use and Indications for Use as the cleared predicate device, ARTIA Tissue Matrix (K142326). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a 3mm diameter circular pattern of perforations (holes) throughout the tissue matrix.

LTM-Perforated Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/ or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. LTM-Perforated Surgical Mesh is intended for single patient one-time use only.

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital. The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. HPTM is intended for single patient, one-time use only.

HP Tissue Matrix is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation.