510(k) Report

Devices descending from K041632

27 later devices reach Minimesh Polypropylene Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+1K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+1K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+1K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+1K060018Trulene MeshSutures India Pvt., Ltd.20060—
+1K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+2K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+2K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+2K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+2K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+2K081327RelimeshHerniamesh S.R.L.20080—
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+3K123914Restorelle Y ContourColoplast A/S20132—
+3K122794Upsylon Y MeshBoston Scientific Corp20120—
+3K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+4K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+4K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K173527Digitex Delivery DeviceColoplast A/S20180—
+5K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—