FDA 510(k) Application Details - K242536

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K242536
Device Name	Insufflator, Laparoscopic
Applicant	TauTona Group 604 Fifth Ave Suite D Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Mike Blanchette 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	08/26/2024
Decision Date	10/15/2024
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