About This 510(k) Submission
K230127 is an FDA 510(k) clearance for the Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 6, 2023, 232 days after receiving the submission on January 17, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.