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Stero View Endoscopic System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013952

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K013952 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 Stero View Endoscopic System is a minimally invasive endoscopic device designed for stereoscopic visualization of internal surgical sites. It provides three-dimensional imaging to enhance precision during procedures in the peritoneal cavity, thoracic cavity, and peritoneum, supporting complex minimally invasive surgeries.

This system is intended for use with compatible robotic or endoscopic instrument control systems and is supplied as a reusable medical device. It is regulated under FDA 510(k) clearance (K013952) and is classified under product code GCJ. The device requires proper maintenance and calibration to ensure accurate stereoscopic imaging and is not intended for single-use applications.

Frequently asked questions

What is the Stero View Endoscopic System used for?

The Stero View Endoscopic System is designed for stereoscopic (3D) visualization during minimally invasive surgeries. It enhances precision by providing detailed imaging of internal surgical sites in the peritoneal cavity, thoracic cavity, and peritoneum. This is particularly useful for complex procedures where depth perception and clarity are critical, such as robotic-assisted surgeries.

Is the Stero View Endoscopic System reusable or single-use?

The Stero View Endoscopic System is explicitly designed for reusable applications. It requires proper maintenance and calibration to ensure accurate stereoscopic imaging over multiple uses. This distinction is important for facilities managing inventory and sterilization protocols.

What types of surgical procedures benefit most from this system?

This system is most beneficial for procedures requiring high precision in confined spaces, such as surgeries in the peritoneal cavity (e.g., abdominal or pelvic surgeries) and thoracic cavity (e.g., lung or heart-related procedures). The 3D imaging capability helps surgeons navigate complex anatomy more effectively, reducing the risk of complications.

How is the Stero View Endoscopic System maintained to ensure optimal performance?

The system requires regular maintenance and calibration to preserve its stereoscopic imaging accuracy. Since it is reusable, facilities must follow manufacturer guidelines for cleaning, inspection, and servicing to prevent degradation of performance. Proper maintenance ensures consistent visualization quality during surgical procedures.

What regulatory pathway does the Stero View Endoscopic System follow?

The Stero View Endoscopic System is regulated under the FDA 510(k) clearance pathway, with the specific clearance number K013952. It was determined to be substantially equivalent to a predicate device and is classified under product code GCJ. This classification is relevant for healthcare providers and facilities when evaluating compliance and procurement.

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: Intuitive | DE | Hersteller der da Vinci und Ion Systeme, Intuitive Surgical Stero View Endoscopic System, Intuitive | Maker of Da Vinci & Ion Robotic Systems, Intuitive Surgical Stereo View Endoscopic System, Model Svs-1 (K990188 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA 510(k) K013952 24 fields · synced Oct 1, 2026