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FDA 510(k)

Hydro Irrigation System

K-Number: K261544 · 2026-06-17

ApplicantStryker Instruments
Decision Date2026-06-17
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: EOB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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