FDA 510(k) Application Details - K212786

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K212786
Device Name	Insufflator, Laparoscopic
Applicant	Core Access Surgical Technologies, Inc. 3495 Piedmont Road, NE Building 11, Suite 905 Atlanta, GA 30305 US Other 510(k) Applications for this Company
Contact	Marianne D. Jacklyn 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	09/01/2021
Decision Date	02/23/2022
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