510(k) K990441

INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 by Sandhill Scientific, Inc. — Product Code FFX

K990441 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300". The FDA issued a decision of Substantially Equivalent on May 12, 1999. 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.