510(k) K101458

LINA XCISE MODEL MOR-1515 by Lina Medical Aps — Product Code HET

K101458 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "LINA XCISE MODEL MOR-1515". The FDA issued a decision of Substantially Equivalent on March 11, 2011. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Lina Medical Aps has at least 10 other 510(k) clearances on record.