Clearance Summary
SOFSILK received FDA 510(k) clearance under submission number K964581, sponsored by United States Surgical, A Division of Tyco Healthc. 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 1997-01-16.
- Submission: K964581
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5030
- Decision date: 1997-01-16
Classification & Regulation
This clearance is catalogued under FDA product code GAP and 21 CFR 878.5030, within the General, Plastic Surgery review panel as a Class II device.