CryoOne 5115
CryoOne 5115 is a Class II device made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K060395 on 24 Feb 2006 and listed in FDA GUDID since 5 Jul 2020 (UDI-DI 04053815079163), 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 | Number04053815079163 | Date5 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060395 | Date24 Feb 2006 | StatusActive |
Official records
- AccessGUDID record 04053815079163
- FDA 510(k) database K060395
Across registries
- FDA 510(k) K060395 decided 24 Feb 2006 Active
- FDA GUDID UDI-DI 04053815079163 listed 5 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K060395
- Listed FDA GUDID 04053815079163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CryoOne
- Generic name
- Localized cutaneous/musculoskeletal cryotherapy unit
- Model / Ref / Catalog
- 5115
- Primary DI / UDI-DI
- 04053815079163
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Localized cutaneous/musculoskeletal cryotherapy unit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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