Identity
- Trade Name
- CryoProbe™ FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Model / Reference
- CryoProbe M FDA UDI
Identifiers
- Catalog Number
- S-HO-CMPR-XX-902 FDA UDI
- Primary DI / UDI-DI
- 15407008481008 FDA UDI
- 510(k) Number
- K024009 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
CryoProbe™ by H & O Equipments SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General cryosurgical system, cryogen gas, mechanical.
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- Wallach — CooperSurgical, Inc. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
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Cleared under the same submission
K024009 also covers:
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
- CryoProbe — H & O Equipments SA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- H & O Equipments SA
Sources (1)
- FDA UDI 8ab5baf8-4309-4569-83fb-538bd034d23c 35 fields · synced May 30, 2026