Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)— 510(k) K232646

Name: FDA 510(k) clearance K232646
Creator: U.S. Food and Drug Administration
Published: 2024-05-24

Substantially Equivalent

Cook Biotech Incorporated

FDA 510(k) clearance K232646 for Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9), Substantially Equivalent on 2024-05-24. Applicant: Cook Biotech Incorporated. Device class: 2.

Clearance details

Applicant: Cook Biotech Incorporated
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2023-08-30
Decision date: 2024-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHJ

view all

K260266 — Tympendi (810)2026-08-18
K161000 — Biodesign Otologic Repair Graft2016-05-11
K150594 — Biodesign Otologic Repair Graft2015-09-16
K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI2013-09-12
K121360 — BIODESIGN ENT REPAIR GRAFT2013-02-27

More clearances from Cook Biotech Incorporated

view all

K201000 — Biodesign Staple Line Reinforcement2020-07-13
K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft2019-12-27
K171817 — Biodesign Diaphragmatic Hernia Graft2018-03-13
K162934 — Biodesign Parastomal Hernia Repair Graft2017-07-10
K170016 — Biodesign Fistula Plug2017-06-21

Recalls naming K232646

K-number listed on FDA's recall record

Z-0832-2025 — Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.Class II·Ongoing·Cook Biotech, Inc.·20241122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232646.

Data sourced from openFDA. This site is unofficial and independent of the FDA.