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FDA 510(k)

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)

K-Number: K220895 · 2022-04-22

ApplicantStryker
Decision Date2022-04-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2022-04-22 under approval number K220895. 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 Pendulum Camera Head (1688310130)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Stryker. The 510(k) number is K220895.

When was 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) approved by the FDA?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) received FDA 510(k) clearance on 2022-04-22, under approval number K220895.

What company makes 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) is manufactured by Stryker.

What is the FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)?

The FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) 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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