C2 CryoBalloon Focal Controller FG-1012
C2 CryoBalloon Focal Controller FG-1012 is a Class II device made by C2 Therapeutics, Inc., listed in FDA GUDID since 19 Oct 2016 (UDI-DI 00854924006125), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00854924006125 | Date19 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 00854924006125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- C2 CryoBalloon Focal Controller
- Generic name
- High-pressure medical gas hose
- Model / Ref / Catalog
- FG-1012
- Primary DI / UDI-DI
- 00854924006125
- FDA product code
- GEH
- GMDN term
- High-pressure medical gas hose
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).
- VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) by Cryosurgery, Inc.
- CryoFreeze Wart and Skin Tag Remover by Cryosurgery, Inc.
- Dermal Cooling System by R2 Dermatology
- IceSphere 1.5 CX Cryoablation Needle by GALIL MEDICAL LTD
- CRYO-HIT, MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4, EP5T2, EP5T3, EP5T5, EP6T5, EP7T3, EP7T5, EP8T3, AND E by GALIL MEDICAL LTD
- Visual-ICE™ MRI H7493961070000 by Boston Scientific
- ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter by Erbe Elektromedizin GmbH
- CMS Oncoprobe by Cryomedical Sciences, Inc.
- Cryomedics 5000 Cryoprobes by Spembly Medical, Ltd.
- UC-Care Warming System by UC-CARE LTD