About This 510(k) Submission
K240276 is an FDA 510(k) clearance for the PillCam? Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software, a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II — Special Controls, product code NEZ), submitted by Given Imaging Ltd. (D.B.A. Medtronic) (Yoqneam Northern, IL). The FDA issued a Cleared decision on May 10, 2024, 100 days after receiving the submission on January 31, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1300.