CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
FDA 510(k) clearance K012497 · decided 2001-10-30
Clearance details
- K-number
- K012497
- Device name
- CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-03
- Decision date
- 2001-10-30
- Days to decision
- 88 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 |
|---|---|---|
| Urethral Warming System-Galil Medical Warming Catheter. The product is contained within pr recall (Z-1698-2008) | Galil Medical | 2008-09-03 |