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Device Explorer · FDA GUDID · GMDN 61875

Endoscopic electrosurgical electrode, monopolar, single-use

A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.

US‑registered devices1,435in commercial distribution
Companies53labelers on GUDID
Single‑use88%of device records
Sterile86%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Orange Surgical Instruments, Llc53537%
Livsmed987%
Conmed Corporation715%
Covidien Lp705%
U.S. Surgitech Inc.685%
Atc Technologies, Inc.493%
Boston Scientific Corporation473%
Finemedix Co.,Ltd.413%

Top labelers

CompanyDevicesShare
Orange Surgical Instruments, Llc53537%
Livsmed987%
Conmed Corporation715%
Covidien Lp705%
U.S. Surgitech Inc.685%
Atc Technologies, Inc.493%
Boston Scientific Corporation473%
Finemedix Co.,Ltd.413%
Megadyne Medical Products, Inc.322%
Gyrus Acmi, Llc312%
Encision, Inc.302%
Surgical Innovations Limited292%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PowerWire 14 Radiofrequency Guidewire KitPowerWire Pulse RF Guidewire KitPowerWire Pro Radiofrequency Guidewire KitPowerWire Radiofrequency GuideWire KitNykanen Radiofrequency WireNykanen Radiofrequency Wire kitMonopolar ScissorsMonopolar SpatulaMonopolar HookDisposable SphincterotomeLaparoscopic Monopolar Electrode, Spatula HookLaparoscopic Monopolar Electrode, J HookLaparoscopic Monopolar Electrode, L HookDisposable Monopolar Atraumatic Intestinal ForceDisposable Monopolar Uterus Grasping ForcepsDisposable Monopolar Mixter Forceps

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 & Accessories1,456
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES164
GCJLaparoscope, General & Plastic Surgery83
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL78
DXFCatheter, Septostomy77
KNSUnit, electrosurgical, endoscopic (with or without accessori64

GMDN & GCC registration

  • GMDN code 61875 · non‑implantable
  • Single‑use 88% · sterile 86% · Rx‑only 93% · 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) · 218Length (Centimeter) · 199Shaft Length (Millimeter) · 73Length (Millimeter) · 57Length (Inch) · 39Angle (degree) · 33

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

How many endoscopic electrosurgical electrode, monopolar, single-use products are registered in the US?

1,435 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic electrosurgical electrode, monopolar, single-use", from 53 companies. The largest labeler is Orange Surgical Instruments, Llc with 37% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), GCJ (Laparoscope, General & Plastic Surgery), 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.

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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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