Consulting Wallah › Device Explorer › Other devices › Electrocautery system electrode
Device Explorer · FDA GUDID · GMDN 45633

Electrocautery system electrode

An active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to bu

US‑registered devices114in commercial distribution
Companies6labelers on GUDID
Single‑use76%of device records
Sterile74%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Gynex Corporation5346%
Dermatologic Lab And Supply, Inc.2118%
Medimax Tech Inc.1917%
Peak Medical Distribution Inc.98%
Rocket Medical Plc76%
Premier Dental Products Company54%

Top labelers

CompanyDevicesShare
Gynex Corporation5346%
Dermatologic Lab And Supply, Inc.2118%
Medimax Tech Inc.1917%
Peak Medical Distribution Inc.98%
Rocket Medical Plc76%
Premier Dental Products Company54%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RocketMediMax TechPremierGeiger Reusable TCU ElectrodeGeiger Reusable TCU ElectrodesGeiger TCU Reusable ElectrodeGeiger Resuable TCU ElectrodeThermalite Disposable TCU ElectrodeThermalite Disposable TCU ElectrodesCarrera Loop ElectrodesCarrera Loop ElectrodeCarrera Ball ElectrodesCarrera Loop ELectrodesBall ElectrodesSquare Loop ElectrodesGynex

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

FDA product codes

CodeNameDevices
HGIElectrocautery, Gynecologic (And Accessories)62
GEIElectrosurgical, Cutting & Coagulation & Accessories34
HQOUnit, Cautery, Thermal, Ac-Powered21
KNSUnit, electrosurgical, endoscopic (with or without accessori3
FGAKit, nephroscope1
FAJCystoscope and accessories, flexible/rigid1

GMDN & GCC registration

  • GMDN code 45633 · non‑implantable
  • Single‑use 76% · sterile 74% · Rx‑only 39% · 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

Outer Diameter (Millimeter) · 7Length (Millimeter) · 2Lumen/Inner Diameter (Millimeter) · 1

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

How many electrocautery system electrode products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocautery system electrode", from 6 companies. The largest labeler is Gynex Corporation with 46% of records.

Which FDA product codes apply?

HGI (Electrocautery, Gynecologic (And Accessories)), GEI (Electrosurgical, Cutting & Coagulation & Accessories), HQO (Unit, Cautery, Thermal, Ac-Powered), KNS (Unit, electrosurgical, endoscopic (with or without accessori)

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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