Clearance Summary
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM received FDA 510(k) clearance under submission number K083770, 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 2009-11-23.
- Submission: K083770
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2009-11-23
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.