# K160332: Stryker SDC3 HD Information Management System with Wireless Device Control Capability

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: May 18, 2016 after 100 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: 8 generations back to K931783 (1993). 11 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121893: Stryker SDC3 HD Information Management System, Stryker Endoscopy (2012) Summary page 4.

## Most influential descendants
- K181258: ConnectedOR Hub with Device and Voice Control (2018), 10 descendants of its own
- K192172: Connected OR Hub with Device and Voice Control (2019), 9 descendants of its own
- K201434: Connected OR Hub with Voice Control, Connected OR Hub with Device Control (2020), 8 descendants of its own
- K212055: Connected OR Hub with Device and Voice Control (2021), 6 descendants of its own
- K220108: SDC4K Information Management System with Device and Voice Control Package (2022), 5 descendants of its own

## Indications for use
The SDC3 is indicated for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, 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 and examination of the evacuated cardiac chamber during performance of valve replacement. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Source page: https://510kreport.com/device/K160332
Methodology: https://510kreport.com/methodology