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FDA 510(k)

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

K-Number: K222079 · 2022-10-11

ApplicantStryker Endoscopy
Decision Date2022-10-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 2022-10-11 under 510(k) number K222079. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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 2022-10-11. The listed applicant is Stryker Endoscopy. The 510(k) number is K222079.

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 2022-10-11, under 510(k) number K222079.

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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Related Devices (Code: GCJ)

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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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