510(k) Report

Devices descending from K013718

153 later devices reach Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082216TBD Ethicon MeshETHICON, Inc.20081—
+1K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+1K053414Mentor Novasilk MeshMentor Corp.20058—
+1K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+1K033376Ugytex MeshSofradim Production200470—
+1K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+2K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+2K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+2K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+2K102815Surelift Prolapse SystemNeomedic International20110—
+2K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+2K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+2K073287Prevadh MeshSofradim Production200817—
+2K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+2K060329Endofast Reliant SystemEndogun Medical Systems20062—
+2K060018Trulene MeshSutures India Pvt., Ltd.20060—
+2K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+2K051503Ugytex Sual Knit MeshSofradim Production200512—
+2K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+2K040998Modification to Parietex Composite (Pco) MeshSofradim Production200461—
+2K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+2K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+3K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+3K130428CovameshBiomup S.A.20130—
+3K131969Symbotex (TM) Composite MeshSofradim Production201310—
+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—
+3K120506Parietex Composite Ventral PatchSofradim Production201211—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+3K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+3K110815Parietex Optimized Compostie MeshSofradim Production20115—
+3K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K091131Pelvic Floor Repair SystemBoston Scientific20095—
+3K083722AscendCaldera Medical, Inc.20097—
+3K072974Surgimesh XBAspide Medical200832
+3K081126Parietex Composite Mono PM MeshSofradim Production2008151
+3K081327RelimeshHerniamesh S.R.L.20080—
+3K081050Parietex Progrip MeshSofradim Production200815—
+3K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+3K072951Parietene Duo and Quadra Polypropylene MeshesSofradim Production20070—
+3K063712Avaulta Support System/Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.200710—
+3K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+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
+3K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+4K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+4K141721Bovine Pericardium PatchCollafirm, LLC20140—
+4K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+4K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+4K130997NeoveilGunze Limited20133—
+4K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+4K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+4K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+4K123914Restorelle Y ContourColoplast A/S20132—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K120025Surgimesh XB - SkirtedAspide Medical20120—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K103682Parietex ProgripSofradim Production20116—
+4K101519Parietex Plug and PatchSofradim Production20106—
+4K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K101197Parie Tene Progrip MeshSofradim Production20106—
+4K090858Parietex Monofilament Polyester MeshSofradim Production200914—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083839Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.20090—
+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—
+4K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+4K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+4K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+4K082571Avaulta Support SystemC.R. Bard, Inc.20081—
+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—
+4K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+4K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+4K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+5K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+5K173527Digitex Delivery DeviceColoplast A/S20180—