Clearance Summary
COLOPLAST OSTOMY ROD, MODEL 12814 received FDA 510(k) clearance under submission number K052229, sponsored by Coloplast Corp.. 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 2006-10-13.
- Submission: K052229
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4270
- Decision date: 2006-10-13
Classification & Regulation
This clearance is catalogued under FDA product code EZP and 21 CFR 876.4270, within the Gastroenterology, Urology review panel as a Class II device.