Hydro Irrigation System— 510(k) K253679

Name: FDA 510(k) clearance K253679
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K253679 for Hydro Irrigation System, Substantially Equivalent on 2026-05-08. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Applicant: Stryker Instruments
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
Advisory panel: Neurology
Date received: 2025-11-21
Decision date: 2026-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.