
Coloplast Corp.
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ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is an FDA 510(k)-cleared medical device (K180469) manufactured by Coloplast 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 November 5, 2018. Regulation: 8.