Cleared Traditional

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

K232646 · Cook Biotech Incorporated · Ear, Nose, Throat

May 2024

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K232646 is an FDA 510(k) clearance for the Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9), a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on May 24, 2024, 268 days after receiving the submission on August 30, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K232646 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2023
Decision Date	May 24, 2024
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF