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Stryker Urology And Gynecology Hardware System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040390

by Stryker Endoscopy

Identifiers

510(k) Number
K040390 FDA 510(k)
FDA Product Code
HIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1690 FDA 510(k)
Regulation Number
884.1690 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Stryker Urology And Gynecology Hardware System by Stryker Endoscopy — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Endoscopy

Sources (1)

  • FDA 510(k) K040390 24 fields · synced Jun 18, 2026