510(k) Report

Devices descending from K980483

297 later devices reach Mentor Suspend Sling through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+1K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc.200429—
+1K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production20044—
+1K020110Modification to Trelex Mesh Surgical MeshBoston Scientific200238—
+1K012949Uretex Sup Pubourethral SlingSofradim Production20010—
+1K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000113—
+1K992159Surgisis SlingCook Biotech, Inc.1999204—
+2K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20211—
+2K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+2K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+2K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+2K121754Blue Sui SlingBoston Scientific Corp20123—
+2K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+2K090688Cook Urological GraftCook Biotech, Inc.20090—
+2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K072974Surgimesh XBAspide Medical200832
+2K070073Align Urethral Support SystemC.R. Bard, Inc.20071—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+2K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+2K051533I-STOPCl Medical20051—
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K050337Sis Fistula PlugCook Biotech, Inc.200527—
+2K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+2K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+2K040787Modification to Surgical Mesh PolymericBoston Scientific20044—
+2K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+2K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+2K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+2K020654Stratasis Sling KitCook Biotech, Inc.20020—
+2K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.200180—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+3K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20230—
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+3K103787Medeor MatrixKensey Nash Corp.20112—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K093747Align and Align to Urethral Support SystemsC.R. Bard, Inc.20100—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+3K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+3K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+3K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+3K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+3K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+3K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+3K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K070993Topas SystemAmerican Medical Systems, Inc.20071—
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+3K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+3K060018Trulene MeshSutures India Pvt., Ltd.20060—
+3K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+3K052830SportmeshArtimplant AB200644—
+3K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+3K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+3K031188OrthomendTei Biosciences, Inc.200336—
+3K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+3K021056PermacolTissue Science Laboratories, Plc200251—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+4K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K140501Xenmatrix Surgical GraftC. R. Bard20140—
+4K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+4K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—