FDA.report

510(k) K253679

Device
Hydro Irrigation System
Applicant
Stryker Instruments
510(k) number
K253679
Product code
GWG
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-08
Date received
2025-11-21
Regulation
882.1480
Classification name
Endoscope, Neurological
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Divya Sekar
Address
1941 Stryker Way Portage MI US 49002 49002

FDA Registration Numbers

Source Documents

510(k) summary PDF

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