# K210584: SDC3 HD Information Management System with Wireless Device Control Capability

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Mar 18, 2021 after 20 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160332: Stryker SDC3 HD Information Management System with Wireless Device Control Capability, Stryker Endoscopy (2016) Summary page 4.

## Indications for use
The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability system 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 SDC3 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/K210584
Methodology: https://510kreport.com/methodology