VISUAL-ICE CRYOABLATION SYSTEM
FDA 510(k) clearance K113860 · decided 2012-03-12
Clearance details
- K-number
- K113860
- Device name
- VISUAL-ICE CRYOABLATION SYSTEM
- Applicant
- Galil Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-30
- Decision date
- 2012-03-12
- Days to decision
- 73 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
- Lake Jackson, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-I recall (Z-2261-2012) | Galil Medical, Inc. | 2012-08-23 |