
Boston Scientific
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Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers is an FDA 510(k)-cleared medical device (K251291) manufactured by Boston Scientific. 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 2, 2025. Regulation: 8.