510(k) Report

Devices descending from K092207

13 later devices reach Restorelle Polypropylene Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+1K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+1K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+1K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+2K123914Restorelle Y ContourColoplast A/S20132—
+2K122794Upsylon Y MeshBoston Scientific Corp20120—
+2K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+3K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+3K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+3K140116Restorelle Y Contour MeshColoplast A/S20141—
+4K173527Digitex Delivery DeviceColoplast A/S20180—
+4K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—