510(k) Report

Devices descending from K190125

2 later devices reach FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20221—
+2K244015SuperBall-RC™Arcuro Medical, Ltd.20250—