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Device Explorer · FDA GUDID · GMDN 11490

Electrosurgical system generator

An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal abla

US‑registered devices408in commercial distribution
Companies59labelers on GUDID
Single‑use16%of device records
Sterile14%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Cook Incorporated4912%
Smith & Nephew, Inc.4210%
Covidien Lp318%
Joimax Gmbh266%
Medtronic, Inc.266%
Elmed Incorporated246%
Kirwan Surgical Products Llc205%
Coltene/Whaledent Inc184%

Top labelers

CompanyDevicesShare
Cook Incorporated4912%
Smith & Nephew, Inc.4210%
Covidien Lp318%
Joimax Gmbh266%
Medtronic, Inc.266%
Elmed Incorporated246%
Kirwan Surgical Products Llc205%
Coltene/Whaledent Inc184%
Conmed Corporation174%
Coopersurgical, Inc.113%
Olympus Winter & Ibe Gmbh102%
Pearson Dental Supplies, Inc.102%

Company = labeler of record on GUDID. 59 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/ACrossfireNALegato®Endovapor®Vaporflex®Endovapor®2Beamer ESU CE200ErbeERBEAUTOCONn.a.AESCULAPOlympusElectrosurgical Unit MCBLEEP PRECISION™ Integrated System

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

FDA product codes

CodeNameDevices
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES191
GEIElectrosurgical, cutting & coagulation & accessories180
GEIElectrosurgical, Cutting & Coagulation & Accessories112
FYDAPPARATUS, EXHAUST, SURGICAL30
BWAUnit, Electrosurgical Andcoagulation, With Accessories24
EKZUnit, Electrosurgical, And Accessories, Dental19

GMDN & GCC registration

  • GMDN code 11490 · non‑implantable
  • Single‑use 16% · sterile 14% · Rx‑only 90% · 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

Height (Inch) · 1Length (Inch) · 1Width (Inch) · 1Length (Feet) · 1

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

How many electrosurgical system generator products are registered in the US?

408 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrosurgical system generator", from 59 companies. The largest labeler is Cook Incorporated with 12% of records.

Which FDA product codes apply?

GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), GEI (Electrosurgical, cutting & coagulation & accessories), GEI (Electrosurgical, Cutting & Coagulation & Accessories), FYD (APPARATUS, EXHAUST, SURGICAL)

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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