# K242606: Nuvis® Wireless HD Camera System (Nuvis-2K)

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Endoscopy, Inc.
- Decided: Nov 20, 2025 after 447 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K950862 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213860: ArthroFree Wireless Surgical Camera System, Lazurite Holdings, LLC (2022) Summary page 5.

## Indications for use
The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.

Source page: https://510kreport.com/device/K242606
Methodology: https://510kreport.com/methodology