SunMed 8-1053-95
by SunMed
SunMed 8-1053-95 is a medical device (FDA Class II; FDA product code BXN, Stimulator, Nerve, Battery-Powered) made by SunMed, cleared under FDA 510(k) K153045 on 13 May 2016 and listed in FDA GUDID since 1 Aug 2023 (UDI-DI 10889483171844), 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 | Number10889483171844 | Date1 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153045 | Date13 May 2016 | StatusActive |
Official records
- AccessGUDID record 10889483171844
- FDA 510(k) database K153045
Across registries
- FDA 510(k) K153045 decided 13 May 2016 Active
- FDA GUDID UDI-DI 10889483171844 listed 1 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K153045
- Listed FDA GUDID 10889483171844
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- Withdrawn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 / Ref / Catalog
- 8-1053-95
- Primary DI / UDI-DI
- 10889483171844
- 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
Similar devices
Other devices filed under FDA product code BXN (STIMULATOR, NERVE, BATTERY-POWERED).
- MYOGUIDE SYSTEM MODEL 8008 by Intronix Technologies Corp.
- STIMULATOR, BATTERY POWERED by Intermedics, Inc.
- MYOTEST - NERVE STIMULATOR by Biometer Intl. A/S
- ASCEND by NEUROMETRIX, INC.
- MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 by Stockert GmbH
- NERVE STIMULATOR, DIGITAL PERIPHERAL by C. R. Bard, Inc.
- CLAVIS by Medtronic A/S
- NERVE STIMULATORS by Rule Medical Instruments, Inc.
- STIMUPLEX-DIG-RC NERVE STIMULATOR by B. Braun Medical, Inc.
- STIMPOD ST2-3010 NERVE STIMULATOR by XAVANT TECHNOLOGY (PTY) LTD