510(k) Report

Devices descending from K010035

86 later devices reach Ivs Tunneller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd.20080—
+1K050516T-SlingHerniamesh S.R.L.200613—
+1K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+2K083722AscendCaldera Medical, Inc.20097—
+2K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+2K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc.200810—
+2K063713Ams Smart Sling SystemAmerican Medical Systems, Inc.20071—
+2K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+3K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+3K103022KIMNeomedic International S.L.20110—
+3K102815Surelift Prolapse SystemNeomedic International20110—
+3K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+3K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+3K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc.20105—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+3K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+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—
+3K082216TBD Ethicon MeshETHICON, Inc.20081—
+3K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+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—
+3K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc.20070—
+3K070993Topas SystemAmerican Medical Systems, Inc.20071—
+3K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+3K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+4K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+4K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+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—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K103418Desara MiniCaldera Medical, Inc.20110—
+4K112609Desara MeshCaldera Medical, Inc.20113—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+4K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+4K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+4K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+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—
+5K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K132069Desara Mesh, Desara BlueCaldera Medical, Inc.20131—
+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—
+5K121928Desara SLCaldera Medical, Inc.20130—
+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—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+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—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+6K150016Vertessa LiteCaldera Medical, Inc.20150—
+6K140843Desara Blue OV, Desara Blue SSCaldera Medical20140—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—