GX1-1285H
by Nissha Medical Technologies Ltd
GX1-1285H is a Class II device made by Nissha Medical Technologies Ltd, cleared under FDA 510(k) K203494 on 23 Feb 2021 and listed in FDA GUDID since 18 Jun 2025 (UDI-DI 15060842920197), active as of 12 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 | Number15060842920197 | Date18 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203494 | Date23 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 15060842920197
- FDA 510(k) database K203494
Across registries
- FDA 510(k) K203494 decided 23 Feb 2021 Active
- FDA GUDID UDI-DI 15060842920197 listed 18 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K203494
- Listed FDA GUDID 15060842920197
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical return electrode, single-use
- Model / reference
- GX1-1285H
- Primary DI / UDI-DI
- 15060842920197
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical return electrode, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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