
Phoenix Bioengineering, Inc.
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SEXTON CYSTOTOMY URINE PUMP (SCUP2) is an FDA 510(k)-cleared medical device (K904434) manufactured by Phoenix Bioengineering, 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 January 31, 1991. Regulation: 8.