510(k) Report

Devices descending from K211346

2 later devices reach BLUE 400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20260—
+1K240215Blue 400; Blue 400 SCarl Zeiss Meditec, AG20240—