Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
FDA 510(k) clearance K173037 · decided 2017-11-21
Clearance details
- K-number
- K173037
- Device name
- Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
- Applicant
- Galil Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-28
- Decision date
- 2017-11-21
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Arden Hills, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.