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FDA 510(k)

SDC4K Information Management System with Device and Voice Control Package

K-Number: K220108 · 2022-02-09

ApplicantStryker Endoscopy
Decision Date2022-02-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SDC4K Information Management System with Device and Voice Control Package is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2022-02-09 under approval number K220108. 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 SDC4K Information Management System with Device and Voice Control Package?

SDC4K Information Management System with Device and Voice Control Package is a medical device that received FDA 510(k) clearance on 2022-02-09. It is manufactured by Stryker Endoscopy. The 510(k) number is K220108.

When was SDC4K Information Management System with Device and Voice Control Package approved by the FDA?

SDC4K Information Management System with Device and Voice Control Package received FDA 510(k) clearance on 2022-02-09, under approval number K220108.

What company makes SDC4K Information Management System with Device and Voice Control Package?

SDC4K Information Management System with Device and Voice Control Package is manufactured by Stryker Endoscopy.

What is the FDA product code for SDC4K Information Management System with Device and Voice Control Package?

The FDA product code for SDC4K Information Management System with Device and Voice Control Package is GCJ.

Related Clinical Trials

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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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