FDA 510(k) Application Details - K190378

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K190378
Device Name	Instrument, Biopsy
Applicant	Bioncise NV Bodemstraat 16 Wellen 3500 BE Other 510(k) Applications for this Company
Contact	Jaak Janssens Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2019
Decision Date	05/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review