# K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew, Inc.
- Decided: Aug 23, 2019 after 113 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: 7 generations back to K833587 (1983). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application, Smith & Nephew (2016) Summary page 4.

## Most influential descendants
- K221740: Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448) (2022), 0 descendants of its own

## Indications for use
The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals. Additionally, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Source page: https://510kreport.com/device/K191177
Methodology: https://510kreport.com/methodology