FDA 510(k) Application Details - K243886

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K243886
Device Name	Instrument, Biopsy
Applicant	INRAD, Inc 4375 Donker Court SE Kentwood, MI 49512 US Other 510(k) Applications for this Company
Contact	Heidi Halverson 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	12/18/2024
Decision Date	04/29/2025
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