# K033132: Stryker Switchpoint Infinity

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Communications Corp.
- Decided: Sep 2, 2004 after 338 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931783 (1993). 12 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022393: Merdoc System, Stryker Endoscopy (2003) Summary page 1.
- K010754: Nurse's Assistant O.R. Control System, Valmed Corp. (2001) Summary page 1.
- K020640: Ksea SCB Media Control, KARL STORZ Endoscopy-America, Inc. (2002) Summary page 1.
- (no number) Stryker Switchpoint III: named in the summary without a submission number

## Most influential descendants
- 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
- K161122: Sony  IP Converter NU-IP40S (2016), 1 descendant of its own
- K123426: Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS (2013), 1 descendant of its own
- K060717: Nurse Assistant 1.7 O.R. Control System (2006), 1 descendant of its own

## Recalls of this device
- Aug 23, 2011 · Not classified · Z-0138-2012: Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
- Apr 30, 2010 · Not classified · Z-1803-2010: Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a froz
- Apr 15, 2010 · Not classified · Z-1641-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1643-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1640-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1645-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1642-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1644-2010: Installation records are incomplete.
- Apr 1, 2008 · Not classified · Z-2467-2008: Product at times experiences intermittent signal loss due to electromagnetic interference.
- Oct 3, 2007 · Not classified · Z-0302-2008: Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.
- Oct 3, 2007 · Not classified · Z-0303-2008: Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.

## Indications for use
The Switchpoint InfinityTM Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy SidneTM System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity TM Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity TM Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery. The Stryker Switchpoint Infinity TM Control System is indicated for use with the Stryker Endoscopy Sidne TM System [510(k) # K022393] and SidneT M compatible endoscopic and general surgery devices. The users of Switchpoint Infinity T M Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, radiologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.

Source page: https://510kreport.com/device/K033132
Methodology: https://510kreport.com/methodology