510(k) Report

Devices descending from K161000

1 later device reach Biodesign Otologic Repair Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…Cook Biotech Incorporated202401