About This 510(k) Submission
K211684 is an FDA 510(k) clearance for the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II — Special Controls, product code NEZ), submitted by Given Imaging Ltd. (Medtronic) (Yoqneam Northern, IL). The FDA issued a Cleared decision on August 27, 2021, 87 days after receiving the submission on June 1, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1300.