Hydro Irrigation System— 510(k) K261544
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K261544 for Hydro Irrigation System, Substantially Equivalent on 2026-06-17. Applicant: Stryker Instruments. Device class: 2.
Summary
Stryker Instruments' Hydro Irrigation System is filed under EOB, flexible or rigid nasopharyngoscopes. The name describes an irrigation system rather than a scope, and the record doesn't explain the fit.
Class II, 21 CFR 874.4760. Ear, Nose, and Throat is both the classification panel and the review panel. It came in as a Traditional 510(k).
Stryker filed from Portage, Michigan. Review took 40 calendar days (May 8 to June 17, 2026).
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.