FDA 510(k)

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

K-Nummer: K254014 · 2026-01-13

Entscheidungsdatum2026-01-13

ProduktcodeGCJ

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K254014. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Stryker Endoscopy. The 510(k) number is K254014.

When did Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control receive FDA 510(k) clearance?

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2026-01-13, under 510(k) number K254014.

Who is the listed applicant for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

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

What is the FDA product code for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is GCJ.

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