About This 510(k) Submission
K113062 is an FDA 510(k) clearance for the ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES, a Telescope, Rigid, Endoscopic (Class II — Special Controls, product code FBP), submitted by Endoservice Optical Instruments GmbH (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on August 21, 2012, 312 days after receiving the submission on October 14, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.