510(k) K201832

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 by Olympus Medical Systems Corp. — Product Code HET

K201832 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5". The FDA issued a decision of Substantially Equivalent on September 17, 2021. 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.