Edge 400
Edge 400 is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Infinium Medical, Inc., cleared under FDA 510(k) K220138 on 5 Oct 2022 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 00852087007607), active as of 22 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 | Number00852087007607 | Date15 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220138 | Date5 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 00852087007607
- FDA 510(k) database K220138
Across registries
- FDA 510(k) K220138 decided 5 Oct 2022 Active
- FDA GUDID UDI-DI 00852087007607 listed 15 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K220138
- Listed FDA GUDID 00852087007607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edge
- Generic name
- Electrosurgical system
- Model / reference
- 400
- Primary DI / UDI-DI
- 00852087007607
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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