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Big-Tip™

FDA UDI

Class II (US FDA UDI)

by RF Medical Co., Ltd.

Identity

Trade Name
BIG-TIP™ FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Model / Reference
BT 1010B FDA UDI

Identifiers

Primary DI / UDI-DI
08809295141014 FDA UDI
510(k) Number
K193355 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Big-Tip™ by RF Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar.

Cleared under the same submission

K193355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RF Medical Co., Ltd.

Sources (1)

  • FDA UDI 045d3b42-4119-424e-b715-604e39a4f10b 33 fields · synced May 31, 2026