About This 510(k) Submission
K251019 is an FDA 510(k) clearance for the BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Bioteque Corporation (Taipei, TW). The FDA issued a Cleared decision on December 22, 2025, 264 days after receiving the submission on April 2, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.