SDC3 HD Information Management System with Wireless Device Control Capability— 510(k) K210584

Substantially Equivalent

Stryker

FDA 510(k) clearance K210584 for SDC3 HD Information Management System with Wireless Device Control Capability, Substantially Equivalent on 2021-03-18. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2021-02-26
Decision date: 2021-03-18
Decision: Substantially Equivalent
Clearance type: Special
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.