DSE1125
DSE1125 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K850108 on 11 Apr 1985 and listed in FDA GUDID since 30 Apr 2016 (UDI-DI 20613994801412), active as of 8 Nov 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 | Number20613994801412 | Date30 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK850108 | Date11 Apr 1985 | StatusActive |
Official records
- AccessGUDID record 20613994801412
- FDA 510(k) database K850108
Across registries
- FDA 510(k) K850108 decided 11 Apr 1985 Active
- FDA GUDID UDI-DI 20613994801412 listed 30 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K850108
- Listed FDA GUDID 20613994801412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Subdermal needle electrode
- Model / reference
- DSE1125
- Primary DI / UDI-DI
- 20613994801412
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Subdermal needle electrode
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 15.0 MillimeterLength — 20.0 MillimeterLength — 2.5 Meter
Similar devices in this category
Other devices filed under Subdermal needle electrode.