510(k) K960810

BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM by Marlo Surgical Technology — Product Code HET

K960810 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM". The FDA issued a decision of Substantially Equivalent on October 21, 1996. 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.