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Device Explorer · FDA GUDID · GMDN 57944

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during e

US‑registered devices496in commercial distribution
Companies33labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Smith & Nephew, Inc.7615%
Covidien Lp6814%
Elliquence, Llc6212%
Hangzhou Ags Medtech Co., Ltd.5411%
Gyrus Acmi, Llc418%
Soniquence, Llc275%
Aesculap Ag184%
New Deantronics Taiwan Ltd.173%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.7615%
Covidien Lp6814%
Elliquence, Llc6212%
Hangzhou Ags Medtech Co., Ltd.5411%
Gyrus Acmi, Llc418%
Soniquence, Llc275%
Aesculap Ag184%
New Deantronics Taiwan Ltd.173%
C&S Medical Co., Ltd.173%
Lina Medical Aps112%
Conmed Corporation112%
Livanova Usa, Inc.102%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ENTire IRE SystemNALiNA PowerBlade™N/AErbeAESCULAPCAIMANWECKPILLINGFLOW FLEXTENDLYNX COBLATIONARIS COBLATION TURBINATE REDUCTION WANDFASTSEAL 6.0 HEMOSTASIS WANDTopazHALOCOBLATION

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 & Accessories247
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES244
GEIElectrosurgical, cutting & coagulation & accessories75
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessori42
KNSUnit, electrosurgical, endoscopic (with or without accessori14
KGEForceps, Biopsy, Electric12

GMDN & GCC registration

  • GMDN code 57944 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 85% · 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) · 59Length (Feet) · 40Outer Diameter (Millimeter) · 35Length (Inch) · 19Length (Millimeter) · 10Catheter Gauge (French) · 9

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

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

496 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic electrosurgical handpiece/electrode, bipolar, single-use", from 33 companies. The largest labeler is Smith & Nephew, Inc. with 15% of records.

Which FDA product codes apply?

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