Clearance Summary
SUTULENE received FDA 510(k) clearance under submission number K943220, sponsored by Sutures , Ltd.. 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 1994-12-05.
- Submission: K943220
- Applicant / Sponsor: Sutures , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 1994-12-05
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.