510(k) Report

Devices descending from K112322

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+1K123914Restorelle Y ContourColoplast A/S20132—
+1K122794Upsylon Y MeshBoston Scientific Corp20120—
+2K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+2K140116Restorelle Y Contour MeshColoplast A/S20141—
+3K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—