510(k) K192534

CrossBay Endometrial Tissue Sampler (ETS) by Crossbay Medical — Product Code HHK

K192534 is an FDA 510(k) premarket notification submitted by Crossbay Medical for the device "CrossBay Endometrial Tissue Sampler (ETS)". The FDA issued a decision of Substantially Equivalent on March 25, 2020. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Crossbay Medical has at least 5 other 510(k) clearances on record.