510(k) Report

Devices descending from K091131

5 later devices reach Pelvic Floor Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+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
+4K173527Digitex Delivery DeviceColoplast A/S20180—