510(k) K910578

MCLAUGHLIN LAPAROSCOPIC GRASPER by Marlo Surgical Technology — Product Code HIS

K910578 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "MCLAUGHLIN LAPAROSCOPIC GRASPER". The FDA issued a decision of Substantially Equivalent on April 3, 1991. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.