
KARL STORZ Endoscopy-America, Inc.
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Image1 S CCU, Image1 S 4U Camera Head is an FDA 510(k)-cleared medical device (K201135) manufactured by KARL STORZ Endoscopy-America, Inc.. 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 August 31, 2020. Regulation: 8.