510(k) Report

Devices descending from K945377

39 later devices reach Trelex Natural (R) Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020110Modification to Trelex Mesh Surgical MeshBoston Scientific200238—
+2K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20211—
+2K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+2K121754Blue Sui SlingBoston Scientific Corp20123—
+2K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+2K040787Modification to Surgical Mesh PolymericBoston Scientific20044—
+2K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+3K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20230—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+3K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K060018Trulene MeshSutures India Pvt., Ltd.20060—
+3K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+4K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+4K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+4K081327RelimeshHerniamesh S.R.L.20080—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+5K123914Restorelle Y ContourColoplast A/S20132—
+5K122794Upsylon Y MeshBoston Scientific Corp20120—
+5K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—