FDA 510(k)

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

Número K: K260185 · 2026-02-18

Data da decisão2026-02-18

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K260185. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Stryker Endoscopy. The 510(k) number is K260185.

When did 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality receive FDA 510(k) clearance?

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 510(k) number K260185.

Who is the listed applicant for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

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.

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