Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control— 510(k) K222079

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K222079 for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control, Substantially Equivalent on 2022-10-11. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-15
Decision date: 2022-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.