Clearance Summary
UNITIP HIGH RESOLUTION CATHETER received FDA 510(k) clearance under submission number K062222, sponsored by Unisensor AG. 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 2007-03-15.
- Submission: K062222
- Applicant / Sponsor: Unisensor AG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2007-03-15
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.