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Nuvis Wireless HD Camera System Nuvis-2K

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242606

by Integrated Endoscopy, Inc.

Identifiers

510(k) Number
K242606 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 Nuvis Wireless HD Camera System (Nuvis-2K) is a sterile wireless HD reusable camera head designed for use in diagnostic and operative endoscopic procedures. It supplies visualization of an interior cavity when attached to an arthroscope or light source and a clinic-supplied video system.

The system is paired to a Wireless Base Station to enable viewing and recording of pertinent data during arthroscopic examinations. It is supplied sterile and intended for reusable use. Authorizations include FDA 510(k) clearance under K242606.

Frequently asked questions

What is the Nuvis Wireless HD Camera System (Nuvis-2K) used for?

The Nuvis Wireless HD Camera System (Nuvis-2K) is designed for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity when attached to an arthroscope or light source and a clinic-supplied video system.

Is the Nuvis Wireless HD Camera System (Nuvis-2K) sterile and reusable?

Yes, the Nuvis Wireless HD Camera System (Nuvis-2K) is supplied sterile and intended for reusable use, as stated in the device description, allowing for multiple uses after proper reprocessing while maintaining sterility at point of use.

How does the Nuvis Wireless HD Camera System (Nuvis-2K) enable viewing and recording during procedures?

The system is paired to a Wireless Base Station to enable viewing and recording of pertinent data during arthroscopic examinations, allowing real-time visualization and data capture when connected to a clinic-supplied video system.

What regulatory authorization does the Nuvis Wireless HD Camera System (Nuvis-2K) have?

The Nuvis Wireless HD Camera System (Nuvis-2K) has FDA 510(k) clearance under K242606, as indicated in the AUTHORIZATIONS and SPECIFICATIONS fields, confirming its regulatory pathway as a substantially equivalent device.

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: Nuvis® Wireless HD Camera System (Nuvis-2K) (K242606) — FDA 510 (k ..., Nuvis Scope - Integrated Endoscopy, PDF integrated endoscopy Nuvis-2K Wireless HD Camera System ... - Manuals+, Nuvis® Wireless HD Camera System (Nuvis-2K) — FDA K242606

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Integrated Endoscopy, Inc.

Sources (1)

  • FDA 510(k) K242606 24 fields · synced Sep 24, 2026