Clearance Summary
CRIT-LINE CLIP (CLIC) received FDA 510(k) clearance under submission number K121599, sponsored by Fresenius Medical Care-North America. 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 2012-11-09.
- Submission: K121599
- Applicant / Sponsor: Fresenius Medical Care-North America
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2012-11-09
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.