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Device Explorer · FDA GUDID · GMDN 57972

Radio-frequency ablation system

An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous

US‑registered devices292in commercial distribution
Companies12labelers on GUDID
Single‑use63%of device records
Sterile62%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Boston Scientific Neuromodulation Corporation24283%
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.197%
Acessa Health Inc.83%
Joimax Gmbh52%
Boston Scientific Corporation52%
Merit Medical Systems, Inc.31%
Vein360 Llc31%
Halt Medical, Inc31%

Top labelers

CompanyDevicesShare
Boston Scientific Neuromodulation Corporation24283%
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.197%
Acessa Health Inc.83%
Joimax Gmbh52%
Boston Scientific Corporation52%
Merit Medical Systems, Inc.31%
Vein360 Llc31%
Halt Medical, Inc31%
Smith & Nephew, Inc.10%
Avanos Medical, Inc.10%
Angiodynamics, Inc.10%
H.S. Hospital Service Spa10%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DophiVaporflex®Legato®VULCANSTAR™SpineSTAR®Endovenous Radiofrequency Ablation (RFA) CatheteAcessa ProVu Dual Foot PedalAcessa ProVu PFG Table ClampAcessa ProVu SystemAcessa ProVu Planar Field Generator (PFG)Acessa ProVu Handpiece CableAcessa ProVu HandpieceAcessa Pad CableAcessa PadsGuidance field generator

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GXIPROBE, RADIOFREQUENCY LESION234
GXDGENERATOR, LESION, RADIOFREQUENCY133
GEIElectrosurgical, Cutting & Coagulation & Accessories42
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)11
ITXTransducer, Ultrasonic, Diagnostic7
IYOSystem, Imaging, Pulsed Echo, Ultrasonic7

GMDN & GCC registration

  • GMDN code 57972 · non‑implantable
  • Single‑use 63% · sterile 62% · Rx‑only 96% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 1Height (Centimeter) · 1Width (Centimeter) · 1Depth (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

How many radio-frequency ablation system products are registered in the US?

292 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radio-frequency ablation system", from 12 companies. The largest labeler is Boston Scientific Neuromodulation Corporation with 83% of records.

Which FDA product codes apply?

GXI (PROBE, RADIOFREQUENCY LESION), GXD (GENERATOR, LESION, RADIOFREQUENCY), GEI (Electrosurgical, Cutting & Coagulation & Accessories), HFG (Coagulator, Laparoscopic, Unipolar (And Accessories))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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