Clearance Summary
BIODESIGN ENT REPAIR GRAFT received FDA 510(k) clearance under submission number K121360, sponsored by Cook Biotech Incorprated. 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 2013-02-27.
- Submission: K121360
- Applicant / Sponsor: Cook Biotech Incorprated
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2013-02-27
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.