CRYOCARE CS SURGICAL SYSTEM
FDA 510(k) clearance K101333 · decided 2010-06-14
Clearance details
- K-number
- K101333
- Device name
- CRYOCARE CS SURGICAL SYSTEM
- Applicant
- Endocare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-12
- Decision date
- 2010-06-14
- Days to decision
- 33 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
- Austin, TX, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an acce recall (Z-0825-2013) | Healthtronics, Inc. | 2013-02-15 |
| CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and recall (Z-1275-2012) | Healthtronics, Inc. | 2012-03-21 |