510(k) Report

Devices descending from K051245

9 later devices reach Polyform Synthetic Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171271Polyform Synthetic MeshBoston Scientific Corporation20170—
+1K071957Pinnacle Pelvic Floor Repair KitsBoston Scientific Corp200773
+2K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+2K091131Pelvic Floor Repair SystemBoston Scientific20095—
+2K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+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
+5K173527Digitex Delivery DeviceColoplast A/S20180—