SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
FDA 510(k) clearance K060144 · decided 2006-02-13
Clearance details
- K-number
- K060144
- Device name
- SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-19
- Decision date
- 2006-02-13
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usa recall (Z-1613-2012) | Galil Medical, Inc. | 2012-05-16 |