About This 510(k) Submission
K984444 is an FDA 510(k) clearance for the INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Sandhill Scientific, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on January 11, 1999, 28 days after receiving the submission on December 14, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.