# K050209: Smith & Nephew Control Digital Operating Room System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 23, 2005 after 299 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 K931783 (1993). 34 ancestors in all.
3 later devices descend 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)
- K981993: Olympus Integrated Endosurgery System Endoalpha, The Olympus Optical Co. (1998) Summary page 2.
- K990691: Hermes Operating Room Control Center, Computer Motion, Inc. (1999) Summary page 2.
- K022393: Merdoc System, Stryker Endoscopy (2003) Summary page 2.

## Most influential descendants
- K070556: Brainsuite Net (2007), 2 descendants of its own
- K161122: Sony  IP Converter NU-IP40S (2016), 1 descendant of its own
- K191678: IP Converter (2020), 0 descendants of its own

## Indications for use
The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and OR. staff.

Source page: https://510kreport.com/device/K050209
Methodology: https://510kreport.com/methodology