# K221740: Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448)

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew, Inc.
- Decided: Oct 20, 2022 after 127 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: 8 generations back to K833587 (1983). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head, Smith and Nephew, Inc. (2019) Summary page 4.

## Indications for use
The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

Source page: https://510kreport.com/device/K221740
Methodology: https://510kreport.com/methodology
