510(k) K905759

HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS by Marlo Surgical Technology — Product Code HET

K905759 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.