About This 510(k) Submission
K211934 is an FDA 510(k) clearance for the APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on November 10, 2022, 506 days after receiving the submission on June 22, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.