510(k) K941743

CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP by Cabot Medical Corp. — Product Code HIG

K941743 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP". The FDA issued a decision of Substantially Equivalent on April 19, 1995. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.