Clearance Summary
WOUND PROTECTOR received FDA 510(k) clearance under submission number K120061, sponsored by Covidien, Formerly US Surgical A Divison of Tyco H. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-03-27.
- Submission: K120061
- Applicant / Sponsor: Covidien, Formerly US Surgical A Divison of Tyco H
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2012-03-27
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.