510(k) K002427

SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 by Sandhill Scientific, Inc. — Product Code FFX

K002427 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.