510(k) Report

Devices descending from K223589

2 later devices reach Grappler Suture Anchor R3FLEX IOL System through their predicates, nearest generation first.

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