# K010754: Nurse's Assistant O.R. Control System

- Pathway: 510(k) (Traditional)
- Applicant: Valmed Corp.
- Decided: Aug 15, 2001 after 155 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
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Computer Motion’s Hermes Operating Room Control Center: named in the summary without a submission number
- (no number) Olympus EndoAlpha: named in the summary without a submission number
- (no number) Karl Storz KSEA SCB-RUI: named in the summary without a submission number
- (no number) Hill-Rom, Inc.’s BrightStar©: named in the summary without a submission number
- (no number) American Sterilizer Co.’s Quantum®, SQ24: named in the summary without a submission number
- (no number) Getinge/Castle, Inc. OptiView©, 500 series: named in the summary without a submission number

## Most influential descendants
- K033132: Stryker Switchpoint Infinity (2004), 8 descendants of its own
- K050829: Nurse's Assistant 1.7 O.R. Control System (2005), 3 descendants of its own
- K100852: Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 (2010), 2 descendants of its own
- K070556: Brainsuite Net (2007), 2 descendants of its own
- K052740: Nurse's Assistant 1.7 O.R. Control System (2005), 2 descendants of its own

## Indications for use
The Nurse's Assistant is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R." lights, and to operate VCRs, monitors, video printers, radios, and CD players. The Val Med Nurse's Assistant is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, 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, internal 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/K010754
Methodology: https://510kreport.com/methodology