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Device Explorer · FDA GUDID · GMDN 43053

Rigid video laparoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are

US‑registered devices198in commercial distribution
Companies12labelers on GUDID
Single‑use4%of device records
Sterile4%labelled sterile
Prescription22%Rx‑only share
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Share of device records

Surgical Direct, Inc.14875%
Karl Storz Gmbh & Co. Kg95%
Olympus Medical Systems Corp.63%
Olympus Winter & Ibe Gmbh63%
Integra Lifesciences Production Corporation63%
Santa Barbara Imaging Systems, Inc.53%
Schölly Fiberoptic Gmbh42%
Activ Surgical, Inc.42%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.14875%
Karl Storz Gmbh & Co. Kg95%
Olympus Medical Systems Corp.63%
Olympus Winter & Ibe Gmbh63%
Integra Lifesciences Production Corporation63%
Santa Barbara Imaging Systems, Inc.53%
Schölly Fiberoptic Gmbh42%
Activ Surgical, Inc.42%
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.42%
Fujifilm Corporation32%
Xenocor, Inc.21%
270 Surgical Ltd11%

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

Brand names on the register (sample)

SurroundScope EndoscopeENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPEENDOEYE FLEX DEFLECTABLE VIDEOSCOPEFUJIFILMTipVision™NATIPCAM1OlympusXenoscope 30°Xenoscope 0°ActivSight Laparoscope 10mm 0 Degree NIRActivSight Laparoscope 5.5mm 0 Degree NIRActivSight Laparoscope 10mm 30 Degree NIRActivSight Laparoscope 5.5mm 30 Degree NIRPristinePIxa

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

FDA product codes

CodeNameDevices
HRXArthroscope148
GCJLaparoscope, General & Plastic Surgery28
HETLaparoscope, Gynecologic (And Accessories)19
GCJLaparoscope, general & plastic surgery14
FETEndoscopic Video Imaging System/Component, Gastroenterology-7
NWBEndoscope, Accessories, Narrow Band Spectrum7

GMDN & GCC registration

  • GMDN code 43053 · non‑implantable
  • Single‑use 4% · sterile 4% · Rx‑only 22% · 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

No structured size data on the register.

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

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

198 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid video laparoscope", from 12 companies. The largest labeler is Surgical Direct, Inc. with 75% of records.

Which FDA product codes apply?

HRX (Arthroscope), GCJ (Laparoscope, General & Plastic Surgery), HET (Laparoscope, Gynecologic (And Accessories)), GCJ (Laparoscope, general & plastic surgery)

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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