510(k) K061268

G-LIX TISSUE GRASPER by Usgi Medical — Product Code HET

K061268 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "G-LIX TISSUE GRASPER". The FDA issued a decision of Substantially Equivalent on July 31, 2006. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Usgi Medical has at least 10 other 510(k) clearances on record.