SunMed 8-1053-60
by SunMed
SunMed 8-1053-60 is a Class II device made by SunMed, cleared under FDA 510(k) K121743 on 28 Mar 2013 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 10889483005835), 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 | Number10889483005835 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121743 | Date28 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 10889483005835
- FDA 510(k) database K121743
Across registries
- FDA 510(k) K121743 decided 28 Mar 2013 Active
- FDA GUDID UDI-DI 10889483005835 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K121743
- Listed FDA GUDID 10889483005835
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SunMed
- Generic name
- Block-monitoring peripheral nerve electrical stimulation system
- Model / reference
- 8-1053-60
- Primary DI / UDI-DI
- 10889483005835
- 510(k) Number
- FDA product code
- BXN
- GMDN term
- Block-monitoring peripheral nerve electrical stimulation system
- Device class
- Class II
- Regulation number
- 868.2775
- GUDID distribution status
- In Commercial Distribution
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