Cryocare CN2 System
510(k) K062175
Cryocare CN2 System is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Endocare, Inc., cleared under FDA 510(k) K062175 on 28 Aug 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062175 | Date28 Aug 2006 | StatusActive |
Official records
- FDA 510(k) database K062175
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEH
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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