Speedicath
510(k) K023254
Speedicath is a Class II device made by Coloplast Corp., cleared under FDA 510(k) K023254 on 27 Jan 2003, 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 | NumberK023254 | Date27 Jan 2003 | StatusActive |
Official records
- FDA 510(k) database K023254
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- Withdrawn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
Similar devices
Other devices filed under FDA product code GBM (Catheter, Urethral).
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- OPEN ENDED URETERAL CATHETER by Van-Tec, Inc.
- ADI CATHETER WITH VALVE by Asia Dynamics, Inc.
- URI-CATH CATHETER by Gesco Intl., Inc.
- ThinkMed Intermittent Catheter with/without Hydrophilic Coating by Thinkmed Medical Technology Co., Ltd.