Histofreezer 1001-0294
Histofreezer 1001-0294 (36F1C) is a Class II device made by Cryoconcepts, LP, cleared under FDA 510(k) K990877 on 14 Jun 1999 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00850077006098), 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 | Number00850077006098 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990877 | Date14 Jun 1999 | StatusActive |
Official records
- AccessGUDID record 00850077006098
- FDA 510(k) database K990877
Across registries
- FDA 510(k) K990877 decided 14 Jun 1999 Active
- FDA GUDID UDI-DI 00850077006098 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K990877
- Listed FDA GUDID 00850077006098
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Histofreezer
- Generic name
- General cryosurgical system, cryogen gas, mechanical
- Model / Ref / Catalog
- 1001-0294, 36F1C
- Primary DI / UDI-DI
- 00850077006098
- 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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