Clearance Summary
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft received FDA 510(k) clearance under submission number K191696, sponsored by Cook Biotech Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-12-27.
- Submission: K191696
- Applicant / Sponsor: Cook Biotech Incorporated
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2019-12-27
Classification & Regulation
This clearance is catalogued under FDA product code OXN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.