
Orthoconcept, Inc.
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UROPUMP* FLUID MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K894363) manufactured by Orthoconcept, 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 10, 1989. Regulation: 8.