About This 510(k) Submission
K002427 is an FDA 510(k) clearance for the SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026, 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 June 22, 2001, 318 days after receiving the submission on August 8, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.