510(k) Report

Devices descending from K002721

113 later devices reach Ams Triangle Silicone-Coated Sling and Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072974Surgimesh XBAspide Medical200832
+1K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+1K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc.200429—
+1K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.200180—
+2K120025Surgimesh XB - SkirtedAspide Medical20120—
+2K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+2K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+2K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+2K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+2K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+2K070993Topas SystemAmerican Medical Systems, Inc.20071—
+2K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+2K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+3K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+3K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+3K102815Surelift Prolapse SystemNeomedic International20110—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+3K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+3K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+3K060329Endofast Reliant SystemEndogun Medical Systems20062—
+3K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+3K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+3K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+4K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+4K123914Restorelle Y ContourColoplast A/S20132—
+4K122794Upsylon Y MeshBoston Scientific Corp20120—
+4K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K083722AscendCaldera Medical, Inc.20097—
+4K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+4K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+4K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+4K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+5K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+5K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+5K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+5K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+5K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+5K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+5K082216TBD Ethicon MeshETHICON, Inc.20081—
+5K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+5K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+6K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K173527Digitex Delivery DeviceColoplast A/S20180—
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+6K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+6K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+6K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+6K120327VertessaCaldera Medical, Inc.20125—
+6K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+6K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+6K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+6K091131Pelvic Floor Repair SystemBoston Scientific20095—
+6K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+7K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+7K151083BioBridge Collagen MatrixFibralign Corporation20169—
+7K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+7K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+7K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+7K122440Restorelle LColoplast Corp.201211
+7K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—