510(k) K170603

Tao Brush I.U.M.C. Endometrial Sampler by Cook Incorporated — Product Code HFE

K170603 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Tao Brush I.U.M.C. Endometrial Sampler". The FDA issued a decision of Substantially Equivalent on May 24, 2017. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. Cook Incorporated has at least 10 other 510(k) clearances on record.