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FDA 510(k)

1788 4K Camera System with Advanced Imaging Modality

K-Number: K233327 · 2024-01-09

ApplicantStryker Endoscopy
Decision Date2024-01-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1788 4K Camera System with Advanced Imaging Modality is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2024-01-09 under approval number K233327. 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 1788 4K Camera System with Advanced Imaging Modality?

1788 4K Camera System with Advanced Imaging Modality is a medical device that received FDA 510(k) clearance on 2024-01-09. It is manufactured by Stryker Endoscopy. The 510(k) number is K233327.

When was 1788 4K Camera System with Advanced Imaging Modality approved by the FDA?

1788 4K Camera System with Advanced Imaging Modality received FDA 510(k) clearance on 2024-01-09, under approval number K233327.

What company makes 1788 4K Camera System with Advanced Imaging Modality?

1788 4K Camera System with Advanced Imaging Modality is manufactured by Stryker Endoscopy.

What is the FDA product code for 1788 4K Camera System with Advanced Imaging Modality?

The FDA product code for 1788 4K Camera System with Advanced Imaging Modality is GCJ.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 28584684 Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA. Journal of pathology informatics (2017)

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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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