FDA 510(k) Application Details - K203192

Device Classification Name	More FDA Info for this Device
510(K) Number	K203192
Device Name	NaviCam Xpress Stomach System
Applicant	AnX Robotica Corp 1047 Serpentine Lane Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Shoshana (Shosh) Friedman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2020
Decision Date	05/04/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review