510(k) Report

Devices descending from K020110

38 later devices reach Modification to Trelex Mesh Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20211—
+1K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+1K121754Blue Sui SlingBoston Scientific Corp20123—
+1K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+1K040787Modification to Surgical Mesh PolymericBoston Scientific20044—
+1K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+2K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20230—
+2K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+2K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+2K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+2K060018Trulene MeshSutures India Pvt., Ltd.20060—
+2K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+3K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+3K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+3K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+3K081327RelimeshHerniamesh S.R.L.20080—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+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
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+5K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K173527Digitex Delivery DeviceColoplast A/S20180—
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—