Sunmed 7-6515-22
by SunMed
Sunmed 7-6515-22 is a Class II device made by SunMed, cleared under FDA 510(k) K082815 on 8 Oct 2008 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 10889483005613), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889483005613 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082815 | Date8 Oct 2008 | StatusActive |
Official records
- AccessGUDID record 10889483005613
- FDA 510(k) database K082815
Across registries
- FDA 510(k) K082815 decided 8 Oct 2008 Active
- FDA GUDID UDI-DI 10889483005613 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K082815
- Listed FDA GUDID 10889483005613
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sunmed
- Generic name
- Indwelling urethral drainage balloon catheter, non-antimicrobial
- Model / reference
- 7-6515-22
- Primary DI / UDI-DI
- 10889483005613
- 510(k) Number
- FDA product code
- EZL
- GMDN term
- Indwelling urethral drainage balloon catheter, non-antimicrobial
- Device class
- Class II
- Regulation number
- 876.5130
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 22 French
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