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Device Explorer · FDA GUDID · GMDN 56296

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (

US‑registered devices1,498in commercial distribution
Companies38labelers on GUDID
Single‑use97%of device records
Sterile97%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Aspen Surgical Products, Inc.41528%
Kirwan Surgical Products Llc22815%
Adeor Medical Ag16911%
Jiangsu Hope Biomedical Science&Technology Co.,Ltd.966%
Katalyst Surgical Llc926%
Stryker Corporation705%
Aesculap, Inc.554%
Medtronic Navigation, Inc.513%

Top labelers

CompanyDevicesShare
Aspen Surgical Products, Inc.41528%
Kirwan Surgical Products Llc22815%
Adeor Medical Ag16911%
Jiangsu Hope Biomedical Science&Technology Co.,Ltd.966%
Katalyst Surgical Llc926%
Stryker Corporation705%
Aesculap, Inc.554%
Medtronic Navigation, Inc.513%
Telea Electronic Engeenering Srl413%
Ethicon Endo-Surgery, Llc403%
Synergetics Usa, Inc.322%
Sutter Medizintechnik Gmbh312%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MalisSERFAS EnergySpetzler-MalishoboatOlympusnxt™ Bipolar ForcepsSUPRA Non-Stick Bipolar ForcepsVitalitecBIPOL.PEN 23G 2PIN TAPER 12/BXBIPOL.PEN 23G TPD LEMO 12/BXBIPOL.PEN 20GA LEMO 12/BXBIPOL.PEN SCLERAL LEMO 12/BXBIPOL.PEN 25G LEMO BLUNT 12BXBIPOL.PEN 25G LEMO TAPER 12BXBIPOL.PEN 25G 2PIN BLUNT 12/BXBIPOL.PEN 25G 2PIN TAPER 12/BX

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 & Accessories1,167
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES227
GEIElectrosurgical, cutting & coagulation & accessories169
GXIProbe, Radiofrequency Lesion8
HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)6
GXZElectrode, Needle2

GMDN & GCC registration

  • GMDN code 56296 · non‑implantable
  • Single‑use 97% · sterile 97% · Rx‑only 96% · 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) · 245Length (Centimeter) · 63Outer Diameter (Millimeter) · 28Length (Millimeter) · 18Width (Centimeter) · 2Width (Millimeter) · 1

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

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

1,498 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery electrosurgical handpiece/electrode, bipolar, single-use", from 38 companies. The largest labeler is Aspen Surgical Products, Inc. with 28% of records.

Which FDA product codes apply?

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

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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