510(k) K243527

High Flow Insufflation Unit (UHI-4) by Olympus Medical Systems Corporation — Product Code HIF

K243527 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "High Flow Insufflation Unit (UHI-4)". The FDA issued a decision of Substantially Equivalent on January 13, 2025. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.