510(k) K924530

CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI by Cabot Medical Corp. — Product Code HET

K924530 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.