FDA 510(k) Application Details - K222462

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K222462
Device Name	Instrument, Biopsy
Applicant	ITP Innovative Tomography Products GmbH Universitaetsstr. 136 Bochum 44799 DE Other 510(k) Applications for this Company
Contact	Dr. Heinz-Werner Henke 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	08/15/2022
Decision Date	01/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review