Clearance Summary
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft received FDA 510(k) clearance under submission number K160869, sponsored by Cook Biotech Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2016-04-29.
- Submission: K160869
- Applicant / Sponsor: Cook Biotech Incorporated
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2016-04-29
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.