Connected OR Hub with Device and Voice Control— 510(k) K212055

Clearance details

Applicant

Stryker Corporation

Product code

Code GCJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2021-07-01

Decision date

2021-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

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 →