Clearance Summary
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY received FDA 510(k) clearance under submission number K103263, sponsored by Covidien, Formerly US Surgical A Divison of Tyco H. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-11-22.
- Submission: K103263
- Applicant / Sponsor: Covidien, Formerly US Surgical A Divison of Tyco H
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2010-11-22
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.