510(k) K182122
K182122 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Ureteric Catheters". The FDA issued a decision of Substantially Equivalent on October 4, 2018. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2018
- Date Received
- August 6, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ureteral, Gastro-Urology
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type