FDA 510(k)

Hydro Irrigation System

Número K: K261544 · 2026-06-17

Data da decisão2026-06-17

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hydro Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261544. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hydro Irrigation System?

Hydro Irrigation System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Stryker Instruments. The 510(k) number is K261544.

When did Hydro Irrigation System receive FDA 510(k) clearance?

Hydro Irrigation System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261544.

Who is the listed applicant for Hydro Irrigation System?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydro Irrigation System?

The FDA product code for Hydro Irrigation System is EOB.

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Fonte oficial

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