FDA 510(k) clearance · back to tracker

KARL STORZ ICG Imaging System with RUBINA® Lens

Karl Storz SE & CO. KG cleared K254242 on 2026-02-26, decision: substantially equivalent

K-number

K254242

Sponsor

Karl Storz SE & CO. KG

Device

KARL STORZ ICG Imaging System with RUBINA® Lens

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-02-26

Product code

OWN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K254242on 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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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.