CRYOCARE SURGICAL SYSTEM
FDA 510(k) clearance K011074 · decided 2002-01-25
Clearance details
- K-number
- K011074
- Device name
- CRYOCARE SURGICAL SYSTEM
- Applicant
- Endocare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-09
- Decision date
- 2002-01-25
- Days to decision
- 291 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
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invas recall (Z-1400-2010) | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. | 2010-04-16 |
| V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a mini recall (Z-1401-2010) | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. | 2010-04-16 |