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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2022-02-09 under 510(k) 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. The listed applicant is Stryker Endoscopy. The 510(k) number is K220108.

When did SDC4K Information Management System with Device and Voice Control Package receive FDA 510(k) clearance?

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

Who is the listed applicant for SDC4K Information Management System with Device and Voice Control Package?

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 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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyRECRUITING

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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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