510(k) Report

Devices descending from K013355

120 later devices reach Sparc Sling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+1K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+1K053296Mentor Aris Suprapubic Surgical KitMentor Corporation20052—
+1K051533I-STOPCl Medical20051—
+1K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+1K031767Mentor Obtape Trans-Obturator TapeMentor Corp.200315—
+1K030123Bioarc SP Sling KitAmerican Medical Systems, Inc.200381—
+1K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021021
+1K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002109—
+1K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002110—
+2K111233Supris Retropubic Sling SystemColoplast A/S20111—
+2K083722AscendCaldera Medical, Inc.20097—
+2K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+2K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+2K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+2K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.200717—
+2K063713Ams Smart Sling SystemAmerican Medical Systems, Inc.20071—
+2K061445Surgimesh WNAspide Medical200752
+2K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+2K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+2K051530Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.American Medical Systems, Inc.200561
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation20057—
+2K042851Mentor Obtape Trans-Obturator Surgical KitMentor Corp.20048—
+2K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc.200437—
+2K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+2K040538Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc.200439—
+2K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+3K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…Coloplast Corp.20240—
+3K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+3K121562Altis Single Incision Cling SystemColoplast A/S20122—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K102815Surelift Prolapse SystemNeomedic International20110—
+3K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+3K092233Surgimesh XDAspide Medical20100—
+3K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc.20102—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+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—
+3K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+3K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+3K081613Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc.20085—
+3K082216TBD Ethicon MeshETHICON, Inc.20081—
+3K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+3K072974Surgimesh XBAspide Medical200832
+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—
+3K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.200716—
+3K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc.20070—
+3K070993Topas SystemAmerican Medical Systems, Inc.20071—
+3K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+4K221874Altis Single Incision Sling SystemColoplast A/S20231—
+4K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+4K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+4K131229Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems201301
+4K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc.20133—
+4K121641Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems201201
+4K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K120327VertessaCaldera Medical, Inc.20125—
+4K110420Ophira Mini Sling SystemPromedon S.A20120—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+4K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+4K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+4K091131Pelvic Floor Repair SystemBoston Scientific20095—
+4K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+4K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.200815—
+5K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+5K183134ArcTV Transvaginal Sling SystemUrocure, LLC20192—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+5K123914Restorelle Y ContourColoplast A/S20132—
+5K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+5K122794Upsylon Y MeshBoston Scientific Corp20120—
+5K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+5K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+5K122440Restorelle LColoplast Corp.201211
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K103418Desara MiniCaldera Medical, Inc.20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+5K081275Boston Scientific Surgical MeshBoston Scientific Corp20085—
+6K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K222293ArcSP Suprapubic Sling SystemUrocure, LLC20220—
+6K222468ArcTO Transobturator Sling SystemUrocure, LLC20220—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—