
Hospal Medical Corp.
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PLUME FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K841791) manufactured by Hospal Medical Corp.. 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 July 8, 1984. Regulation: 8.