510(k) K230127

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 by Micro-Tech (Nanjing) Co., Ltd. — Product Code FGE

K230127 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on September 6, 2023. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.