Clearance Summary
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER received FDA 510(k) clearance under submission number K113572, sponsored by Covidien, Formerly Valleylab, A Division of Tyco H. 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 2012-09-05.
- Submission: K113572
- Applicant / Sponsor: Covidien, Formerly Valleylab, A Division of Tyco H
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2012-09-05
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.