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Device Explorer · FDA GUDID · GMDN 44680

Electrosurgical handpiece, reusable

A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electro

US‑registered devices234in commercial distribution
Companies26labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Steris Corporation6226%
Karl Storz Gmbh & Co. Kg2410%
Cynosure, Llc188%
Gyrus Acmi, Llc177%
Scanlan International Inc167%
Cameron-Miller Inc167%
Gimmi Gmbh136%
Devroye Instruments Belgium125%

Top labelers

CompanyDevicesShare
Steris Corporation6226%
Karl Storz Gmbh & Co. Kg2410%
Cynosure, Llc188%
Gyrus Acmi, Llc177%
Scanlan International Inc167%
Cameron-Miller Inc167%
Gimmi Gmbh136%
Devroye Instruments Belgium125%
Encision, Inc.104%
Accurate Surgical & Scientific Instruments Corporation63%
Kirwan Surgical Products Llc63%
Microline Surgical, Inc.63%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WAW SOFTWAREWAW Duo FUE SystemWAW CHARGING STATIONPUNCH SUPPORT BOXWAW SLIM HANDPIECEEXTERNAL SLEEVE SUPPORT BOXWAW PEDALWAW WIRED HANDPIECEWAW WIRELESS HANDPIECEHermann Medizintechnik GmbHGimmiCLICKLINEROBIROTATIPTAKE-APARTPlasma+

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 & Accessories96
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES88
GCJLaparoscope, general & plastic surgery24
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP20
JOSElectrode, electrosurgical17
GEYMotor, Surgical Instrument, Ac-Powered12

GMDN & GCC registration

  • GMDN code 44680 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 88% · 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

Shaft Length (Millimeter) · 20Outer Diameter (Millimeter) · 20Length (Centimeter) · 15Length (Inch) · 7Width (Millimeter) · 1Outer Diameter (Centimeter) · 1

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

How many electrosurgical handpiece, reusable products are registered in the US?

234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrosurgical handpiece, reusable", from 26 companies. The largest labeler is Steris Corporation with 26% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), GCJ (Laparoscope, general & plastic surgery), ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP)

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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