SpeediCath Flex Coude
510(k) K161672
SpeediCath Flex Coude is a Class II device made by Coloplast Corp., cleared under FDA 510(k) K161672 on 29 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161672 | Date29 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K161672
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GBM
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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