Clearance Summary
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM received FDA 510(k) clearance under submission number K140523, sponsored by Coloplast A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2014-07-24.
- Submission: K140523
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-07-24
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.