510(k) Report

Devices descending from K922916

133 later devices reach Bard Marlex Mesh Dart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical20140—
+1K133198Ultrapro Comfort PlugETHICON, Inc.20140—
+1K120844Medlinx Surgical MeshMedlinx Acala Pte, Ltd.20120—
+1K113552Freedom Inguinal Hernia ImplantInsightra Medical20121—
+1K101519Parietex Plug and PatchSofradim Production20106—
+1K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083—
+1K0709184DDOMECousin Biotech20070—
+1K070224Ultrapro PlugETHICON, Inc.20071—
+1K050969Inclose Surgical Mesh SystemAnulex Technologies, Inc.20050—
+1K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000113—
+1K982575Mesh, Surgical, PolymericUnited States Surgical, A Division of Tyco Healthc19980—
+2K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+2K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132—
+2K072974Surgimesh XBAspide Medical200832
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+2K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc.200429—
+2K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.200180—
+3K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+3K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20161—
+3K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+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—
+3K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+3K070993Topas SystemAmerican Medical Systems, Inc.20071—
+3K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+3K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+4K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+4K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20180—
+4K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K102815Surelift Prolapse SystemNeomedic International20110—
+4K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+4K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+4K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+4K060329Endofast Reliant SystemEndogun Medical Systems20062—
+4K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+4K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+4K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+5K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+5K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+5K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+5K123914Restorelle Y ContourColoplast A/S20132—
+5K122794Upsylon Y MeshBoston Scientific Corp20120—
+5K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K083722AscendCaldera Medical, Inc.20097—
+5K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+5K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+5K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+5K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+6K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+6K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+6K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+6K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+6K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+6K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+6K082216TBD Ethicon MeshETHICON, Inc.20081—
+6K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+6K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+6K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+6K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+7K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+7K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—