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FDA 510(k)

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable

K-Number: K214046 · 2022-05-25

ApplicantStryker
Decision Date2022-05-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2022-05-25 under approval number K214046. 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 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Stryker. The 510(k) number is K214046.

When was 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable approved by the FDA?

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable received FDA 510(k) clearance on 2022-05-25, under approval number K214046.

What company makes 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is manufactured by Stryker.

What is the FDA product code for 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

The FDA product code for 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is GCJ.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026)

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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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