510(k) Report

Devices descending from K211770

3 later devices reach R3ACT Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+2K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+3K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—