Clearance Summary
IDRIVE ULTRA STERILIZATION TRAY received FDA 510(k) clearance under submission number K130532, 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 General Hospital review panel. The statutory decision date of record is 2013-05-30.
- Submission: K130532
- Applicant / Sponsor: Covidien, Formerly US Surgical A Divison of Tyco H
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2013-05-30
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.