510(k) Report

Devices descending from K150594

2 later devices reach Biodesign Otologic Repair Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161000Biodesign Otologic Repair GraftCook Biotech Incorporated20161—
+2K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…Cook Biotech Incorporated202401