510(k) Report

Devices descending from K190817

6 later devices reach HS Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253024ProZip Knotless ImplantRiverpoint Medical20250—
+1K231163HS Fiber SuturesRiverpoint Medical20243—
+1K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+2K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+2K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+2K252201HS FiberRiverpoint Medical20250—