About This 510(k) Submission
K140726 is an FDA 510(k) clearance for the CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Boston Scientific Corp (Marborough, US). The FDA issued a Cleared decision on July 21, 2014, 119 days after receiving the submission on March 24, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.