FDA 510(k) Application Details - K233220

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K233220
Device Name	Instrument, Biopsy
Applicant	SenoRx, Inc. 1625 West 3rd Street Tempe, AZ 85251 US Other 510(k) Applications for this Company
Contact	Kathryn Swanstrom 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	09/28/2023
Decision Date	10/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review