510(k) K123365

OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 by Olympus Medical Systems Corp. — Product Code HET

K123365 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.