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FDA 510(k)

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

K-Number: K260185 · 2026-02-18

ApplicantStryker Endoscopy
Decision Date2026-02-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2026-02-18 under approval number K260185. 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 System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

1688 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 2026-02-18. It is manufactured by Stryker Endoscopy. The 510(k) number is K260185.

When was 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality approved by the FDA?

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality received FDA 510(k) clearance on 2026-02-18, under approval number K260185.

What company makes 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

1688 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 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

The FDA product code for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) 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: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Stryker Endoscopy

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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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