# K230886: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jun 21, 2023 after 82 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: 15 generations back to K931783 (1993). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222079: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control, Stryker Endoscopy (2022) Summary page 4.

## Most influential descendants
- K232157: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (2023), 2 descendants of its own
- K241401: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (2024), 1 descendant of its own
- K254014: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (2026), 0 descendants of its own

## Indications for use
Connected OR Hub with Device and Voice Control: The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device. SDC4K Information Management System with Device and Voice Control: The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

Source page: https://510kreport.com/device/K230886
Methodology: https://510kreport.com/methodology