510(k) Report

Devices descending from K001122

152 later devices reach Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172089PROLENE Soft Polypropylene MeshETHICON, Inc.20170—
+1K163152PROLENE Soft Polypropylene MeshETHICON, Inc.20171—
+1K142091Parietene Macroporous MeshSofradim Production20142—
+1K133889PremiumCousin Biotech Sas20140—
+1K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd.201031
+1K083102Refine Lift SystemAlure Medical, Inc.20091—
+1K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+1K081069Gore Infinit MeshW. L. Gore & Associates, Inc.200821—
+1K053424PopmeshCaldera Medical, Inc.20068—
+1K053158Optilene Mesh LPAesculap, Inc.20065—
+1K043081Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc.200426—
+1K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+1K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+2K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+2K223218Parietene Macroporous MeshSofradim Production20221—
+2K181094Polydioxanone Surgical ScaffoldLntegra Lifesciences20181—
+2K163005TIGR Matrix Surgical MeshNovus Scientific AB20172—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K120327VertessaCaldera Medical, Inc.20125—
+2K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K092538Refine Support System, Model 100.0100Alure Medical, Inc.20100—
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K081777Ventrio Hernia PatchC.R. Bard, Inc.2008144
+2K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+2K060329Endofast Reliant SystemEndogun Medical Systems20062—
+2K060018Trulene MeshSutures India Pvt., Ltd.20060—
+2K061704Optilene MeshAesculap, Inc.20064—
+2K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+2K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc.200525—
+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—
+3K260474Liora Monofilament ScaffoldTELA Bio, Inc.20260—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K142706Modified ONFLEX MeshC.R. Bard, Inc.20150—
+3K142711ONFLEX MeshC.R. Bard, Inc.20151—
+3K132441Bard Ventralex Hernia PatchC.R. Bard, Inc.20130—
+3K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+3K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+3K122440Restorelle LColoplast Corp.201211
+3K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+3K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+3K101928Ventralex ST Hernia PatchC.R. Bard, Inc.201111
+3K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113—
+3K100229Ventrio Hernia PatchC.R. Bard, Inc.201013—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K083722AscendCaldera Medical, Inc.20097—
+3K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083—
+3K081327RelimeshHerniamesh S.R.L.20080—
+3K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+3K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+3K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+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
+4K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.20250—
+4K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.20191—
+4K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+4K150016Vertessa LiteCaldera Medical, Inc.20150—
+4K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132—
+4K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+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—
+4K123914Restorelle Y ContourColoplast A/S20132—
+4K122794Upsylon Y MeshBoston Scientific Corp20120—
+4K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+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—
+4K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+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—
+5K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20161—