Edge 160
Edge 160 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 00852087007584), 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 | Number00852087007584 | Date15 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220138 | Date5 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 00852087007584
- FDA 510(k) database K220138
Across registries
- FDA 510(k) K220138 decided 5 Oct 2022 Active
- FDA GUDID UDI-DI 00852087007584 listed 15 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K220138
- Listed FDA GUDID 00852087007584
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edge
- Generic name
- Electrosurgical system
- Model / reference
- 160
- Primary DI / UDI-DI
- 00852087007584
- 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
Similar devices in this category
Other devices filed under Electrosurgical system.
- Wet-Field® Eraser® 221268150 by Beaver-Visitec International Inc
- SILKRO by Hironic Co., Ltd.
- Voyant Open Fusion Device EB240 by APPLIED MEDICAL RESOURCES CORP.
- POTENZA Tip P1-08 by Jeisys Medical Incorporated
- DIEGO ELITE BB2000SA by Gyrus Acmi, Inc.
- Vaporflex® JVHS32030 by Joimax GmbH
- POTENZA Tip S-25 by Jeisys Medical Incorporated
- Voyant Maryland Fusion Device with Single-Step Activation EB213 by APPLIED MEDICAL RESOURCES CORP.
- Vaporflex® JVHS27527S by Joimax GmbH