Consulting Wallah › Device Explorer › Cardiovascular › Cardiac radio-frequency ablation system generator
Device Explorer · FDA GUDID · GMDN 60784

Cardiac radio-frequency ablation system generator

An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include elec

US‑registered devices108in commercial distribution
Companies5labelers on GUDID
Single‑use65%of device records
Sterile65%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Atricure, Inc.6661%
Medtronic, Inc.2826%
St. Jude Medical, Inc.87%
Stockert Gmbh44%
Biosense Webster Inc22%

Top labelers

CompanyDevicesShare
Atricure, Inc.6661%
Medtronic, Inc.2826%
St. Jude Medical, Inc.87%
Stockert Gmbh44%
Biosense Webster Inc22%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TactiSys™Ampere™INTELLAGEN™ Remote ControlINTELLAGEN™ Remote Control KitINTELLAGEN™ RF Generator KitINTELLAGEN™ RF GeneratorCARDIOBLATE®Isolator Surgical Ablation SystemSubtle Cannula with GuidenContact RF GeneratorEPi-Sense Guided Coagulation System with VisiTraNumeris Tethered Coagulation System with VisiTraSynergy™ Ablation SystemHexaGen™ RF GeneratorCardioblate™ Gemini™-sDiamondTemp™ FASTR RF Generator

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

FDA product codes

CodeNameDevices
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation O37
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fi25
OCLSurgical Device, For cutting, coagulation, and/or ablation o19
OAECatheter, percutaneous, cardiac ablation, for treatment of a15
LPBCardiac ablation percutaneous catheter13
OADcatheter, percutaneous, cardiac ablation, for treatment of a10

GMDN & GCC registration

  • GMDN code 60784 · non‑implantable
  • Single‑use 65% · sterile 65% · Rx‑only 83% · 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

Length (Centimeter) · 21Length (Millimeter) · 5

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

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

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac radio-frequency ablation system generator", from 5 companies. The largest labeler is Atricure, Inc. with 61% of records.

Which FDA product codes apply?

OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation O), OCM (Surgical Cardiac Ablation Device, For Treatment Of Atrial Fi), OCL (Surgical Device, For cutting, coagulation, and/or ablation o), OAE (Catheter, percutaneous, cardiac ablation, for treatment of a)

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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