Hydro Irrigation System— 510(k) K253679
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K253679 for Hydro Irrigation System, Substantially Equivalent on 2026-05-08. Applicant: Stryker Instruments. Device class: 2.
Summary
Stryker Instruments' Hydro Irrigation System is filed under GWG, neurological endoscopes.
Class II, 21 CFR 882.1480. Neurology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Stryker filed from Portage, Michigan. The decision came 168 calendar days after receipt (November 21, 2025 to May 8, 2026).
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
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Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.