Identity
- Trade Name
- Big-Tip EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- Big-Tip , MYOBLATE™ EUDAMED
- Model / Reference
- BT Series EUDAMEDBT-TRIW2030 EUDAMEDBTM 3505QB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809559963307 EUDAMED08809295149416 FDA UDI
- Basic UDI-DI
- 880014291604BD EUDAMED
- 510(k) Number
- K221277 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
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
Yes
Manufacturing Date
No
Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Big-Tip by RF Medical Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K221277 also covers:
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
- BIG-TIP™ — RF Medical Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- RF Medical Co., Ltd.
Sources (2)
- FDA UDI 38ba4699-99a2-49ba-a523-c6fa29ecd63b 33 fields · synced Sep 17, 2026
- EUDAMED 36884a31-8dc5-49c2-9ca4-eb116a483ff6 61 fields · synced Sep 17, 2026