510(k) Report

Devices descending from K982870

3 later devices reach Epifilm Otologic Lamina through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150594Biodesign Otologic Repair GraftCook Biotech Incorprated20152—
+2K161000Biodesign Otologic Repair GraftCook Biotech Incorporated20161—
+3K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…Cook Biotech Incorporated202401