510(k) Report

Devices descending from K071512

20 later devices reach Gynecare Prolift +M* Pelvic Floor Repair Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102815Surelift Prolapse SystemNeomedic International20110—
+1K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+1K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+1K082216TBD Ethicon MeshETHICON, Inc.20081—
+1K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+2K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+2K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+2K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+2K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+2K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+2K091131Pelvic Floor Repair SystemBoston Scientific20095—
+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
+4K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+4K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+4K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K173527Digitex Delivery DeviceColoplast A/S20180—
+5K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—