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Device Explorer · FDA GUDID · GMDN 12291

Rigid optical laparoscope

An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus)

US‑registered devices575in commercial distribution
Companies38labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg5710%
Stryker Corporation539%
Sopro-Comeg Gmbh468%
Elmed Incorporated437%
National Advanced Endoscopy Devices, Inc.417%
Avalign Technologies, Inc.397%
Smith & Nephew, Inc.305%
Schölly Fiberoptic Gmbh254%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg5710%
Stryker Corporation539%
Sopro-Comeg Gmbh468%
Elmed Incorporated437%
National Advanced Endoscopy Devices, Inc.417%
Avalign Technologies, Inc.397%
Smith & Nephew, Inc.305%
Schölly Fiberoptic Gmbh254%
Scivita Medical Technology Co., Ltd.244%
Intuitive Surgical, Inc.224%
Arthrex, Inc.203%
Conmed Corporation203%

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

Brand names on the register (sample)

SPYAIM (Advanced Imaging Modality)Ideal EyesPrecision Ideal EyesNADPM, Endoscopic Fluorescence Camera SystemEndosoLaparoscope3D Laparoscope4K UHD LaparoscopeAMNOTECHD Laparoscope, 3,3mm, 30°, autoclavableHD Laparoscope, 3,3mm, 0°, autoclavableHD3 laparoscope, 5.5mm, 30°, autoclavable, HMHD3 laparoscope, 5.5mm, 0°, autoclavable, HMHermann 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
GCJLaparoscope, general & plastic surgery375
GCJLaparoscope, General & Plastic Surgery155
HETLaparoscope, Gynecologic (And Accessories)83
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)27
NMHLaparoscope And Accessories, Gynecologic, Reprocessed26
IZISystem, X-Ray, Angiographic25

GMDN & GCC registration

  • GMDN code 12291 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 85% · 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

Outer Diameter (Millimeter) · 120Angle (degree) · 54Length (Centimeter) · 37Length (Millimeter) · 10Width (Millimeter) · 7Length (Inch) · 1

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

How many rigid optical laparoscope products are registered in the US?

575 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid optical laparoscope", from 38 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 10% of records.

Which FDA product codes apply?

GCJ (Laparoscope, general & plastic surgery), GCJ (Laparoscope, General & Plastic Surgery), HET (Laparoscope, Gynecologic (And 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.

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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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