510(k) K222059
K222059 is an FDA 510(k) premarket notification submitted by Coloplast for the device "SpeediCath Flex Set". The FDA issued a decision of Substantially Equivalent on September 21, 2022. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Coloplast has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2022
- Date Received
- July 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type