# K091648: Nurse's Assistant O.R. Control System ,1.8

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Integrated Systems (Cmis)
- Decided: Aug 5, 2009 after 57 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: 9 generations back to K931783 (1993). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060717: Nurse Assistant 1.7 O.R. Control System, Conmed Integrated Systems (Cmis) (2006) Summary page 4.
- K033132: Stryker Switchpoint Infinity, Stryker Communications Corp. (2004) Summary page 4.
- K070827: Karl Storz SCB Interface Control, Model 20090120, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 4.

## Indications for use
The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment. The Nurse's Assistant® O.R. Control System, 1.8 is indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialties. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.

Source page: https://510kreport.com/device/K091648
Methodology: https://510kreport.com/methodology