510(k) Report

Devices descending from K010931

80 later devices reach Ams Sacral Colpopexy Sling, Model 72403501 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+1K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+1K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+2K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+2K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+2K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+2K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+2K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+2K060329Endofast Reliant SystemEndogun Medical Systems20062—
+2K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+2K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+2K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+3K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+3K123914Restorelle Y ContourColoplast A/S20132—
+3K122794Upsylon Y MeshBoston Scientific Corp20120—
+3K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+3K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+3K083722AscendCaldera Medical, Inc.20097—
+3K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+3K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+3K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+3K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+3K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+4K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+4K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+4K140116Restorelle Y Contour MeshColoplast A/S20141—
+4K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+4K102815Surelift Prolapse SystemNeomedic International20110—
+4K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+4K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+4K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+4K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+4K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+4K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+4K082216TBD Ethicon MeshETHICON, Inc.20081—
+4K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+4K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+4K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+5K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+5K173527Digitex Delivery DeviceColoplast A/S20180—
+5K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+5K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K120327VertessaCaldera Medical, Inc.20125—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+5K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+5K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+5K091131Pelvic Floor Repair SystemBoston Scientific20095—
+5K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+5K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+6K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+6K151083BioBridge Collagen MatrixFibralign Corporation20169—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+6K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+6K122440Restorelle LColoplast Corp.201211
+6K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+6K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+6K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+7K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+7K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+7K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K150016Vertessa LiteCaldera Medical, Inc.20150—
+7K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K242187BioBrace®Conmed Corporation20241—
+8K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—