FDA 510(k) Application Details - K213683

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K213683
Device Name	Instrument, Biopsy
Applicant	Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City 311121 CN Other 510(k) Applications for this Company
Contact	Zearou Yang 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	11/22/2021
Decision Date	04/22/2022
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