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Device Explorer · FDA GUDID · GMDN 44776

Electrosurgical system

An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a

US‑registered devices892in commercial distribution
Companies48labelers on GUDID
Single‑use46%of device records
Sterile39%labelled sterile
Prescription57%Rx‑only share
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Share of device records

Deroyal Industries, Inc.12414%
Prosurg Inc12214%
Macan Manufacturing11413%
Jeisys Medical Inc.667%
Cynosure, Llc587%
Gyrus Acmi, Llc354%
Henry Schein, Inc.293%
Beaver-Visitec International, Inc.293%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.12414%
Prosurg Inc12214%
Macan Manufacturing11413%
Jeisys Medical Inc.667%
Cynosure, Llc587%
Gyrus Acmi, Llc354%
Henry Schein, Inc.293%
Beaver-Visitec International, Inc.293%
Joimax Gmbh263%
Bonart Co., Ltd.243%
Soniquence, Llc243%
Viol Co.,Ltd.202%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NATaktvollBoston AestheticsNEUROMARK SystemNEUROMARK® Radiofrequency ConsoleNEUROMARK® DeviceGT9 Heavy Ball Electrode (5mm)GT8 Heavy Ball Electrode (2.38mm)GT5 Heavy Wire ElectrodeGT4 Fine Wire ElectrodeGT3 Large Loop ElectrodeGT2 Small Loop ElectrodeGT1 Blade Type ElectrodeART GT E1 Electrode SetE1 Indiference PlateE1 Handpiece (S)

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 & Accessories377
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES216
EKZUnit, Electrosurgical, And Accessories, Dental143
FASElectrode, Electrosurgical, Active, Urological113
GEIElectrosurgical, cutting & coagulation & accessories34
PBXMassager, vacuum, radio frequency induced heat27

GMDN & GCC registration

  • GMDN code 44776 · non‑implantable
  • Single‑use 46% · sterile 39% · Rx‑only 57% · 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

Catheter Gauge (French) · 112Outer Diameter (Inch) · 109Outer Diameter (Millimeter) · 31Length (Centimeter) · 18Length (Millimeter) · 5Shaft Length (Centimeter) · 4

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

How many electrosurgical system products are registered in the US?

892 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrosurgical system", from 48 companies. The largest labeler is Deroyal Industries, Inc. with 14% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), EKZ (Unit, Electrosurgical, And Accessories, Dental), FAS (Electrode, Electrosurgical, Active, Urological)

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.

How do I get quotes?

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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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