# K031979: Conmed Integrated Systems Nurses Assistant

- Pathway: 510(k) (Special)
- Applicant: Conmed Integrated Systems (Cmis)
- Decided: Jul 25, 2003 after 29 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931783 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010754: Nurse's Assistant O.R. Control System, Valmed Corp. (2001) Summary page 5.
- K022270: Modification to Olympus Integrated Endosurgery System Endoalpha, Olympus Optical Co., Ltd. (2002) Summary page 5.
- K030240: Modification to Hermes Operating Room Control Center, Computer Motion, Inc. (2003) Summary page 5.

## Indications for use
The Nurse's Assistant® is a programmable controlier operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment. The Nurse's Assistant®is intended to be used to tum on and off, and adjust certain settings of, endoscopic and surgical cameras. electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 insufflator, surgical lamps, operating room (“O.R.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radios and CD players. The Nurse's Assistant®is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecolcgy, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, intemal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.

Source page: https://510kreport.com/device/K031979
Methodology: https://510kreport.com/methodology