FDA 510(k) Application Details - K223116

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K223116
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Santa Barbara Imaging Systems 340 Storke Road, Suite 101 Goleta, CA 93117 US Other 510(k) Applications for this Company
Contact	Jim Candy Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2022
Decision Date	02/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review