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CryoProbe™ CryoProbe |b White

by H & O Equipments SA

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 United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K024009

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB386SHOCBPLUSPR040 UDI-DI Date6 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024009 Date20 Mar 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024009 decided 20 Mar 2003 Active
  • FDA GUDID UDI-DI B386SHOCBPLUSPR040 listed 6 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024009
  2. Listed FDA GUDID B386SHOCBPLUSPR040

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

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

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from H & O Equipments SA

See all devices from H & O Equipments SA →

Properties

  • Serial number
Other properties (14, all answered No)