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AtriCure cryoICE Cryoablation System (CRYO3)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AtriCure cryoICE Cryoablation System (CRYO3) FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- cryoICE 10cm Cryoablation Probe FDA UDI
- Model / Reference
- CRYO3 FDA UDI
- Description
- cryoICE 10cm Cryoablation Probe FDA UDI
Identifiers
- Catalog Number
- A000925 FDA UDI
- Primary DI / UDI-DI
- 10840143902420 FDA UDI
- 510(k) Number
- K180137 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
AtriCure cryoICE Cryoablation System (CRYO3) by Atricure, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General cryosurgical system, cryogen gas, mechanical.
- 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
- truFreeze — US Endoscopy · Class II
Cleared under the same submission
K180137 also covers:
- AtriCure cryoICE Cryoablation System (CRYO3) — ATRICURE, INC.
- AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) — ATRICURE, INC.
- AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) — ATRICURE, INC.
- cryoICE Cryoablation System — ATRICURE, INC.
- cryoICE Cryoablation System — ATRICURE, INC.
- cryoICE Cryoablation System — ATRICURE, INC.
- cryoICE Cryoablation System — ATRICURE, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Atricure, Inc.
Sources (2)
- FDA UDI 066b8614-948f-4835-b6bb-8a05b4d1c4cd 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026