FDA 510(k) clearance · back to tracker

KARL STORZ ICG Imaging System

Karl Storz SE & CO. KG cleared K232857 on 2023-11-06, decision: substantially equivalent

K-number

K232857

Sponsor

Karl Storz SE & CO. KG

Device

KARL STORZ ICG Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-11-06

Product code

OWN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K232857on 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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Source

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