510(k) K190620
K190620 is an FDA 510(k) premarket notification submitted by Coloplast for the device "SpeediCath Flex Coude Pro". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code GBM (Catheter, Urethral), 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
- July 10, 2019
- Date Received
- March 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type