Clearance Summary
OSTOMY IRRIGATION SET received FDA 510(k) clearance under submission number K121833, 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 2012-07-16.
- Submission: K121833
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5895
- Decision date: 2012-07-16
Classification & Regulation
This clearance is catalogued under FDA product code EXD and 21 CFR 876.5895, within the Gastroenterology, Urology review panel as a Class II device.