510(k) K171607

Bronchi and Gastrointestinal Cytology Brush by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code FDX

K171607 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "Bronchi and Gastrointestinal Cytology Brush". The FDA issued a decision of Substantially Equivalent on July 31, 2017. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical Inc./Cook Endoscopy has at least 6 other 510(k) clearances on record.