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Device Explorer · FDA GUDID · GMDN 63868

Laparoscopic surgery handle

A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synt

US‑registered devices87in commercial distribution
Companies7labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Elmed Incorporated4349%
Aspen Surgical Products, Inc.1517%
Avalign Technologies, Inc.1517%
Sontec Instruments, Inc.1113%
Hermann Medizintechnik Gmbh11%
Surgipros, Llc11%
Alpha Ai Co.,Ltd.11%

Top labelers

CompanyDevicesShare
Elmed Incorporated4349%
Aspen Surgical Products, Inc.1517%
Avalign Technologies, Inc.1517%
Sontec Instruments, Inc.1113%
Hermann Medizintechnik Gmbh11%
Surgipros, Llc11%
Alpha Ai Co.,Ltd.11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Hermann Medizintechnik GmbHSymmetry Secto®Symmetry SurgicalSymmetrySymmetry McintyreSymmetry DixSymmetry GraetherELMEDELMED INCORPORATEDSURGIPROSAxial HandleErgonomic Highly Rigid Plastic Ring HandleERGONOMIC HIGHLY RIGID PLASTIC RING HANDLEAXIAL HANDLEAXIAL RING HANDLEINSULATED METALHANDLE

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

FDA product codes

CodeNameDevices
GCJLaparoscope, General & Plastic Surgery40
GEIElectrosurgical, Cutting & Coagulation & Accessories36
GEIElectrosurgical, cutting & coagulation & accessories10
HETLaparoscope, Gynecologic (And Accessories)8
GDOApplier, Surgical, Clip5
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)2

GMDN & GCC registration

  • GMDN code 63868 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 94% · 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) · 6Length (Millimeter) · 5Outer Diameter (Millimeter) · 5Width (Millimeter) · 2Length (Inch) · 1

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

How many laparoscopic surgery handle products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laparoscopic surgery handle", from 7 companies. The largest labeler is Elmed Incorporated with 49% of records.

Which FDA product codes apply?

GCJ (Laparoscope, General & Plastic Surgery), GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEI (Electrosurgical, cutting & coagulation & accessories), HET (Laparoscope, Gynecologic (And 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.

How do I get quotes?

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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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