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FDA 510(k)

Nuvis® Wireless HD Camera System (Nuvis-2K)

K-Number: K242606 · 2025-11-20

ApplicantIntegrated Endoscopy, Inc.
Decision Date2025-11-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nuvis® Wireless HD Camera System (Nuvis-2K) is a medical device manufactured by Integrated Endoscopy, Inc.. It received FDA 510(k) clearance on 2025-11-20 under approval number K242606. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Nuvis® Wireless HD Camera System (Nuvis-2K) is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Integrated Endoscopy, Inc.. The 510(k) number is K242606.

When was Nuvis® Wireless HD Camera System (Nuvis-2K) approved by the FDA?

Nuvis® Wireless HD Camera System (Nuvis-2K) received FDA 510(k) clearance on 2025-11-20, under approval number K242606.

What company makes Nuvis® Wireless HD Camera System (Nuvis-2K)?

Nuvis® Wireless HD Camera System (Nuvis-2K) is manufactured by Integrated Endoscopy, Inc..

What is the FDA product code for Nuvis® Wireless HD Camera System (Nuvis-2K)?

The FDA product code for Nuvis® Wireless HD Camera System (Nuvis-2K) is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Integrated Endoscopy, Inc.

K191594Nuvis Battery Arthroscope

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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