CryoProbe™ CryoProbe |b White
CryoProbe |b White (S-HO-CBPLUSPR-04) is a general cryosurgical system (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by H & O Equipments SA, cleared under FDA 510(k) K024009 on 20 Mar 2003 and listed in FDA GUDID since 6 Feb 2018 (UDI-DI B386SHOCBPLUSPR040), active as of 23 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 | NumberB386SHOCBPLUSPR040 | Date6 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK024009 | Date20 Mar 2003 | StatusActive |
Official records
- FDA 510(k) database K024009
Across registries
- FDA 510(k) K024009 decided 20 Mar 2003 Active
- FDA GUDID UDI-DI B386SHOCBPLUSPR040 listed 6 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K024009
- Listed FDA GUDID B386SHOCBPLUSPR040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CryoProbe™
- Generic name
- General cryosurgical system, cryogen gas, mechanical
- Model / Ref / Catalog
- CryoProbe |b White, S-HO-CBPLUSPR-04
- Primary DI / UDI-DI
- B386SHOCBPLUSPR040
- 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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