Identity
- Trade Name
- ERBE FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL FDA UDI
- Model / Reference
- 10448-004 FDA UDI
- Description
- ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL FDA UDI
Identifiers
- Catalog Number
- 10448-004 FDA UDI
- Primary DI / UDI-DI
- 04050147019737 FDA UDI
- 510(k) Number
- K051509 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General cryosurgical system, cryogen gas, mechanical
ERBE is a cutting-edge general cryosurgical system designed for clinicians to efficiently destroy and remove malignant or abnormal benign tissue. Utilizing a mechanical regulator to control the flow of cryogen, ERBOCRYO CA Cryosurgical System applies cold from a gaseous or liquid refrigerant (cryogen) to target areas for its destruction and removal.
Similar devices
Also classified as General cryosurgical system, cryogen gas, mechanical.
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- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- CryoProbe™ — H & O Equipments SA · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- Wallach — CooperSurgical, Inc. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
Cleared under the same submission
K051509 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (1)
- FDA UDI b7e34c05-b174-4520-98a3-c5e7eead25c7 37 fields · synced Jul 1, 2026