TRUFREEZE SYSTEM
FDA 510(k) clearance K133258 · decided 2014-06-19
Clearance details
- K-number
- K133258
- Device name
- TRUFREEZE SYSTEM
- Applicant
- CSA Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-23
- Decision date
- 2014-06-19
- Days to decision
- 239 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
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved u recall (Z-0941-2015) | CSA Medical | 2015-01-07 |