510(k) K121833
K121833 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "OSTOMY IRRIGATION SET". The FDA issued a decision of Substantially Equivalent on July 16, 2012. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Coloplast A/S has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2012
- Date Received
- June 22, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Irrigator, Ostomy
- Device Class
- Class II
- Regulation Number
- 876.5895
- Review Panel
- GU
- Submission Type