510(k) Report

Devices descending from K981935

7 later devices reach Polysorb Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202950StitchKit COMBOOrigami Surgical20212—
+1K063536Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group20073—
+2K211792StitchKitOrigami Surgical Inc .20211—
+2K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20082—
+3K221527StitchKitOrigami Surgical Inc .20230—
+3K200392RexsinSm Eng Co., Ltd.20200—
+3K173779Rexmono, PdrexSm Eng Co., Ltd.20180—