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IntelliBlate Microwave Ablation System Console
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref IB-CON510(k) K240480
Identity
- Trade Name
- IntelliBlate Microwave Ablation System Console EUDAMEDFDA UDI
- Generic Name
- Microwave ablation system FDA UDI
- Device Name
- IntelliBlate Microwave Ablation System Console EUDAMEDIntelliBlate microwave ablation system console only for tabletop configuration FDA UDI
- Model / Reference
- IB-CON EUDAMEDFDA UDI
- Description
- IntelliBlate microwave ablation system console only for tabletop configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810563022278 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200145PW EUDAMED
- 510(k) Number
- K240480 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Microwave ablation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Foot-switch, electrical
IntelliBlate Microwave Ablation System Console by Varian Medical Systems, Inc — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240480 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200145PW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000007453
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED fa77dc41-742d-4c8c-9db9-6653df9f4788 85 fields · synced Jun 18, 2026
- FDA UDI 26f3a7a2-1f90-47be-8809-a94076c08ea2 34 fields · synced May 30, 2026
- FDA 510(k) K240480 1 fields · synced May 18, 2026