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FDA 510(k)

Hydro Irrigation System

K-Number: K253679 · 2026-05-08

ApplicantStryker Instruments
Decision Date2026-05-08
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hydro Irrigation System is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2026-05-08 under approval number K253679. The device is classified under product code GWG. It was reviewed by the NE 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 2026-05-08. It is manufactured by Stryker Instruments. The 510(k) number is K253679.

When was Hydro Irrigation System approved by the FDA?

Hydro Irrigation System received FDA 510(k) clearance on 2026-05-08, under approval number K253679.

What company makes Hydro Irrigation System?

Hydro Irrigation System is manufactured by Stryker Instruments.

What is the FDA product code for Hydro Irrigation System?

The FDA product code for Hydro Irrigation System is GWG.

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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