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FDA 510(k)

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)

K-Number: K230216 · 2023-02-23

ApplicantStryker
Decision Date2023-02-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230216. 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 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Stryker. The 510(k) number is K230216.

When did 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) receive FDA 510(k) clearance?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230216.

Who is the listed applicant for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

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

What is the FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

The FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is 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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