About This 510(k) Submission
K203132 is an FDA 510(k) clearance for the AXIOS Stent and Electrocautery Enhanced Delivery System, a Pancreatic Stent, Covered, Metallic, Removable (Class II — Special Controls, product code PCU), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on April 15, 2021, 178 days after receiving the submission on October 19, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5015.