FDA 510(k) Application Details - K232464

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K232464
Device Name	Insufflator, Laparoscopic
Applicant	Freyja Healthcare, LLC 488 Pleasant Street North Andover, MA 01845 US Other 510(k) Applications for this Company
Contact	Ronald Adams Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2023
Decision Date	05/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review