Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control— 510(k) K232157

Clearance details

Applicant

Stryker Corporation

Product code

Code GCJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2023-07-20

Decision date

2023-08-18

Decision

Substantially Equivalent

Clearance type

Special

Location

San Jose, CA, US

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Death

39

Injury

1,638

Malfunction

28,216

Other

11

Total

29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →