510(k) K022023

COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 by Clinical Innovations, Inc. — Product Code KLA

K022023 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500". The FDA issued a decision of Substantially Equivalent on January 7, 2003. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.