Clearance Summary
FORCETRIAD ELECTROSURGICAL GENERATOR received FDA 510(k) clearance under submission number K110268, sponsored by Covidien Lp, Formerly Know AS Valleylab, A Divison. 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 2011-05-31.
- Submission: K110268
- Applicant / Sponsor: Covidien Lp, Formerly Know AS Valleylab, A Divison
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2011-05-31
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.