SpeediCath Standard
by Coloplast
510(k) K180258
SpeediCath Standard is a Class II device made by Coloplast, cleared under FDA 510(k) K180258 on 25 Oct 2018, 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 | NumberK180258 | Date25 Oct 2018 | StatusActive |
Official records
- FDA 510(k) database K180258
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- Withdrawn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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