FDA 510(k) Application Details - K181317

Device Classification Name	Endoscopic Cytology Brush   More FDA Info for this Device
510(K) Number	K181317
Device Name	Endoscopic Cytology Brush
Applicant	Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Sierra Lowe Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2018
Decision Date	02/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review