About This 510(k) Submission
K220112 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 September 7, 2022, 237 days after receiving the submission on January 13, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5015.