CryOmega 800-2001
CryOmega 800-2001 is a Class II device made by Cryoconcepts, LP, cleared under FDA 510(k) K102006 on 6 Oct 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00850077006036), 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 | GUDID listing | Number00850077006036 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102006 | Date6 Oct 2010 | StatusActive |
Official records
- AccessGUDID record 00850077006036
- FDA 510(k) database K102006
Across registries
- FDA 510(k) K102006 decided 6 Oct 2010 Active
- FDA GUDID UDI-DI 00850077006036 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K102006
- Listed FDA GUDID 00850077006036
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CryOmega
- Generic name
- Cryogenic spray, cutaneous
- Model / Ref / Catalog
- 800-2001
- Primary DI / UDI-DI
- 00850077006036
- 510(k) Number
- FDA product code
- GEH
- GMDN term
- Cryogenic spray, cutaneous
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 8 Gram
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