FDA 510(k) Application Details - K242772

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K242772
Device Name	Insufflator, Laparoscopic
Applicant	SmartSurgN Inc 1038 Leigh Ave Ste 101B San Jose, CA 95126 US Other 510(k) Applications for this Company
Contact	Jocelyn Long 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	09/13/2024
Decision Date	04/11/2025
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