FDA 510(k) clearance · back to tracker

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

Stryker cleared K231854 on 2023-09-20, decision: substantially equivalent

K-number

K231854

Sponsor

Stryker

Device

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-09-20

Product code

OWN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K231854on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.