
Karl Storz Endoscopy America
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KARL STORZ ICG Imaging System is an FDA 510(k)-cleared medical device (K212695) manufactured by Karl Storz Endoscopy America. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2021. Regulation: 8.