FDA 510(k) Application Details - K241902

Device Classification Name	More FDA Info for this Device
510(K) Number	K241902
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	LeeAnne Swiridow 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	07/01/2024
Decision Date	10/30/2024
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