510(k) Report

Devices descending from K053414

8 later devices reach Mentor Novasilk Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+1K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+1K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+2K122794Upsylon Y MeshBoston Scientific Corp20120—
+2K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+2K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+3K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+4K173527Digitex Delivery DeviceColoplast A/S20180—