Clearance Summary
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) received FDA 510(k) clearance under submission number K232646, sponsored by Cook Biotech Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2024-05-24.
- Submission: K232646
- Applicant / Sponsor: Cook Biotech Incorporated
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2024-05-24
Classification & Regulation
This clearance is catalogued under FDA product code KHJ and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.