Histofreezer FLEX 200-5052
Histofreezer FLEX 200-5052 (50SM) is a Class II device made by Cryoconcepts, LP, cleared under FDA 510(k) K183601 on 18 Apr 2019 and listed in FDA GUDID since 13 Sep 2020 (UDI-DI 00850077006364), 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 | Number00850077006364 | Date13 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183601 | Date18 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 00850077006364
- FDA 510(k) database K183601
Across registries
- FDA 510(k) K183601 decided 18 Apr 2019 Active
- FDA GUDID UDI-DI 00850077006364 listed 13 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K183601
- Listed FDA GUDID 00850077006364
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Histofreezer FLEX
- Generic name
- General cryosurgical system, cryogen gas, mechanical
- Model / Ref / Catalog
- 200-5052, 50SM
- Primary DI / UDI-DI
- 00850077006364
- 510(k) Number
- FDA product code
- GEH
- GMDN term
- General cryosurgical system, cryogen gas, mechanical
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
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