FDA 510(k) clearance · back to tracker

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

Karl Storz SE & CO. KG cleared K233333 on 2023-11-21, decision: substantially equivalent

K-number

K233333

Sponsor

Karl Storz SE & CO. KG

Device

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-11-21

Product code

OWN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K233333on 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.