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Device Explorer · FDA GUDID · GMDN 58039

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including l

US‑registered devices1,135in commercial distribution
Companies40labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Olympus Medical Systems Corp.19817%
Micro-Tech (Nanjing) Co., Ltd.18116%
Hangzhou Ags Medtech Co., Ltd.17616%
Applied Medical Resources Corporation1009%
Cook Incorporated726%
Zhejiang Chuangxiang Medical Technology Co., Ltd.646%
Genicon, Inc.414%
Telemed Systems404%

Top labelers

CompanyDevicesShare
Olympus Medical Systems Corp.19817%
Micro-Tech (Nanjing) Co., Ltd.18116%
Hangzhou Ags Medtech Co., Ltd.17616%
Applied Medical Resources Corporation1009%
Cook Incorporated726%
Zhejiang Chuangxiang Medical Technology Co., Ltd.646%
Genicon, Inc.414%
Telemed Systems404%
Purple Surgical International Limited272%
Arthrex, Inc.262%
Beijing Zksk Technology Co.,Ltd161%
Conmed Corporation161%

Company = labeler of record on GUDID. 40 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rotatable SnaresNon-Rotatable SnaresDisposable Polyp SnareNADisposable Monopolar Straight ScissorsDisposable Monopolar Curved ScissorsMedtronicOlympusDisposable Polypectomy SnareZKSKSphincterotome / short-wire compatibleSphincterotome short-wire compatibleSingle Use Electrosurgical KnifeADVANTIS(TM) Polypectomy SnarePolypectomy SnareEdgeHog(TM) Polypectomy Snare

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

FDA product codes

CodeNameDevices
FDISnare, Flexible294
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessori274
KNSUnit, electrosurgical, endoscopic (with or without accessori271
GEIElectrosurgical, Cutting & Coagulation & Accessories177
HETLaparoscope, Gynecologic (And Accessories)92
GCJLaparoscope, General & Plastic Surgery90

GMDN & GCC registration

  • GMDN code 58039 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 89% · 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) · 170Outer Diameter (Millimeter) · 134Atherectomy Device Tip Length (Millimeter) · 112Atherectomy Cutter Length (Millimeter) · 112Width (Millimeter) · 19Length (Millimeter) · 19

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

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

1,135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic electrosurgical handpiece/electrode, monopolar, single-use", from 40 companies. The largest labeler is Olympus Medical Systems Corp. with 17% of records.

Which FDA product codes apply?

FDI (Snare, Flexible), KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessori), KNS (Unit, electrosurgical, endoscopic (with or without accessori), GEI (Electrosurgical, Cutting & Coagulation & Accessories)

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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