FDA 510(k) Application Details - K233466

Device Classification Name	More FDA Info for this Device
510(K) Number	K233466
Device Name	Edison System
Applicant	HistoSonics, Inc. 16305 36th Avenue N Suite 300 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Daniel Kosednar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2023
Decision Date	03/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review