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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: K241401 · 2024-08-15

ApplicantStryker Endoscopy
Decision Date2024-08-15
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 a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2024-08-15 under approval number K241401. 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 2024-08-15. It is manufactured by Stryker Endoscopy. The 510(k) number is K241401.

When was Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control approved by the FDA?

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2024-08-15, under approval number K241401.

What company makes 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 manufactured by Stryker Endoscopy.

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 PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42144441 A workflow utilizing general-purpose large language models for efficient structuring and data mining of bone scintigraphy narratives. Scientific reports (2026)

Other Devices by Stryker Endoscopy

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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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