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3D Laparoscope

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252697

by Guangdong Optomedic Technologies, Inc.

Identifiers

510(k) Number
K252697 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 3D Laparoscope is a minimally invasive endoscopic device classified under the nomenclature for laparoscopes (product code GCJ), designed for visualisation of internal abdominal or pelvic organs during surgical procedures. It provides a three-dimensional stereoscopic view, enhancing depth perception and spatial orientation for the surgeon compared to traditional 2D laparoscopes.

This device is supplied as a reusable medical instrument, intended for use in general and plastic surgery settings. It is authorised under FDA 510(k) clearance and MDR compliance, with a product code GCJ under the Gastroenterology and Urology advisory committee classifications. No specific sterility or single-use designation is stated in the provided data.

Frequently asked questions

Is the 3D Laparoscope designed for single-use or can it be reused after sterilization?

The 3D Laparoscope is explicitly described as a reusable medical instrument. Since no single-use designation or sterility requirements are mentioned, it implies the device is intended for repeated use in clinical settings, provided proper cleaning and sterilization protocols are followed between procedures.

What types of surgeries is this device primarily intended for based on its classification?

The 3D Laparoscope falls under the Gastroenterology and Urology advisory committee classifications (product code GCJ) and is described as suitable for general and plastic surgery settings. While this does not define specific clinical indications, it suggests the device is used for procedures requiring internal visualization of abdominal or pelvic organs, such as laparoscopic surgeries in these fields.

How does the 3D Laparoscope differ from traditional 2D laparoscopes in terms of functionality?

The key distinction is that the 3D Laparoscope provides a three-dimensional stereoscopic view, which enhances depth perception and spatial orientation for surgeons compared to the two-dimensional images offered by traditional 2D laparoscopes. This can improve precision during procedures where spatial awareness is critical.

What regulatory pathways has this device undergone, and how does that affect its use?

The 3D Laparoscope has been authorized through FDA 510(k) clearance and MDR compliance, indicating it has met regulatory standards for safety and effectiveness in the U.S. and EU markets. These pathways confirm the device’s suitability for clinical use in minimally invasive surgeries, though actual use must adhere to local healthcare regulations and institutional protocols.

Are there different sizes or models available for this device, or is it supplied in a single configuration?

The provided data does not specify variations in sizes or models for the 3D Laparoscope. Since only a general description is given, buyers or clinicians should confirm specific configurations (e.g., shaft length, tip angles, or optical specifications) directly with the manufacturer, Guangdong Optomedic Technologies, Inc., as these details may vary based on surgical needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 4K-Guangdong OptoMedic Technologies, Inc., Guangdong OptoMedic Technologies, Inc., K252697 FDA 510 (k) - 3D Laparoscope, 3D Laparoscope (K252697) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangdong Optomedic Technologies, Inc.

Sources (2)

  • FDA 510(k) K252697 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026