SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
FDA 510(k) clearance K021261 · decided 2002-07-03
Clearance details
- K-number
- K021261
- Device name
- SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-19
- Decision date
- 2002-07-03
- Days to decision
- 75 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
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved recall (Z-1032-2011) | Galil Medical, Inc. | 2011-02-03 |