Clearance Summary
COLOPLAST URO 2002 UROSTOMY SYSTEM received FDA 510(k) clearance under submission number K844685, sponsored by Coloplast A/S. 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 1985-01-08.
- Submission: K844685
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1985-01-08
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.