Clearance Summary
AFB (ABSORBABLE FOAM BUTTRESS) received FDA 510(k) clearance under submission number K014183, sponsored by J&J Corporate Biomaterials Center. 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 2002-06-12.
- Submission: K014183
- Applicant / Sponsor: J&J Corporate Biomaterials Center
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2002-06-12
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.