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Device Explorer · FDA GUDID · GMDN 32684

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

An 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 endoscop

US‑registered devices5,887in commercial distribution
Companies32labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Surgical Direct, Inc.4,66779%
Steris Corporation3386%
Günter Bissinger Medizintechnik Gmbh1623%
Karl Storz Gmbh & Co. Kg1603%
Integra Lifesciences Production Corporation1222%
Sontec Instruments, Inc.992%
Sutter Medizintechnik Gmbh601%
Integra Microfrance521%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.4,66779%
Steris Corporation3386%
Günter Bissinger Medizintechnik Gmbh1623%
Karl Storz Gmbh & Co. Kg1603%
Integra Lifesciences Production Corporation1222%
Sontec Instruments, Inc.992%
Sutter Medizintechnik Gmbh601%
Integra Microfrance521%
Gimmi Gmbh441%
Richard Wolf Gmbh361%
Aesculap Ag250%
National Advanced Endoscopy Devices, Inc.250%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAMaxMoreSpineGuenter Bissinger Medizintechnik GmbHMicroLap Bipolar Forceps - InsertMicroLap Bipolar Forceps - Insert 200mmMicroLap Bipolar Forceps - HandleMicroLap Bipolar Forceps - Over TubeMicroLap Bipolar Forceps - Over Tube 200mmC35-Bipolar Insert L 33cm D 3,5mmC35-Bipolar Insert L 20cm D 3,5mmC35- Bipolar Maryland Insert L33cm D 3,5mmC35- Bipolar Maryland Insert L20cm D 3,5mmC35-Bipolar Handle L 33cm D 3,5mmC35-Bipolar Tube L 33cm D 3,5mmC35-Bipolar Tube L 20cm D 3,5mmHermann Medizintechnik GmbH

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 & Accessories4,601
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES817
GEIElectrosurgical, cutting & coagulation & accessories400
KNSUnit, electrosurgical, endoscopic (with or without accessori90
HIHHYSTEROSCOPE (AND ACCESSORIES)74
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL49

GMDN & GCC registration

  • GMDN code 32684 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 20% · 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 (Inch) · 169Outer Diameter (Millimeter) · 92Length (Millimeter) · 68Length (Centimeter) · 5Guidewire Diameter (Millimeter) · 2Guidewire Length (Millimeter) · 2

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

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

5,887 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, reusable", from 32 companies. The largest labeler is Surgical Direct, Inc. with 79% 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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