
Custom Ultrasonics, Inc.
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Scope-Assist Flushing Sink is an FDA 510(k)-cleared medical device (K162120) manufactured by Custom Ultrasonics, 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 April 27, 2017. Regulation: 8.