510(k) Report

Devices descending from K963611

120 later devices reach Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.20200—
+1K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+1K972201Patch,Pledget and Intracardiac,Petp,Ptfe,PolypropyleneSulzer Carbomedics, Inc.199801
+1K972651IN-SlingInfluence, Inc.1997115—
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K980482Triangle SlingInfluence, Inc.1998114—
+3K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000113—
+4K072974Surgimesh XBAspide Medical200832
+4K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+4K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc.200429—
+4K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.200180—
+5K120025Surgimesh XB - SkirtedAspide Medical20120—
+5K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+5K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+5K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+5K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+5K070993Topas SystemAmerican Medical Systems, Inc.20071—
+5K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+5K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+6K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+6K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+6K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+6K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+6K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+6K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+6K102815Surelift Prolapse SystemNeomedic International20110—
+6K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+6K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+6K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+6K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+6K090288Orthadapt PRPegasus Biologics, Inc.20097—
+6K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+6K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+6K060329Endofast Reliant SystemEndogun Medical Systems20062—
+6K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+6K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+6K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+7K211132ARISTE AB MeshAriste Medical, LLC20220—
+7K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+7K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+7K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+7K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+7K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+7K123914Restorelle Y ContourColoplast A/S20132—
+7K122794Upsylon Y MeshBoston Scientific Corp20120—
+7K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+7K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+7K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+7K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+7K083722AscendCaldera Medical, Inc.20097—
+7K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+7K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+7K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+7K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+8K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+8K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+8K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+8K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+8K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+8K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+8K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+8K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+8K140116Restorelle Y Contour MeshColoplast A/S20141—
+8K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+8K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+8K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+8K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+8K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+8K082216TBD Ethicon MeshETHICON, Inc.20081—
+8K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+8K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+8K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+8K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+9K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+9K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+9K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+9K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+9K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+9K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+9K173527Digitex Delivery DeviceColoplast A/S20180—
+9K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+9K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+9K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+9K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+9K120327VertessaCaldera Medical, Inc.20125—
+9K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+9K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+9K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+9K091131Pelvic Floor Repair SystemBoston Scientific20095—
+9K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+10K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+10K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+10K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+10K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—