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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 a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2023-02-23 under approval 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. It is manufactured by Stryker. The 510(k) number is K230216.

When was 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) approved by the FDA?

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

What company makes 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is manufactured by Stryker.

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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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

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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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