FDA 510(k) Application Details - K213232

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K213232
Device Name	Instrument, Biopsy
Applicant	Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 US Other 510(k) Applications for this Company
Contact	Daniel Lanois 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	09/30/2021
Decision Date	07/01/2022
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