510(k) K240978

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) by MacroLux Medical Technology Co., Ltd. — Product Code HIH

K240978 is an FDA 510(k) premarket notification submitted by MacroLux Medical Technology Co., Ltd. for the device "SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. MacroLux Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.