FDA 510(k) Application Details - K231960

Device Classification Name	More FDA Info for this Device
510(K) Number	K231960
Device Name	NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
Applicant	AnX Robotica Corporation 6010 W Spring Creek Parkway Plano, TX 75024 US Other 510(k) Applications for this Company
Contact	Tim Thomas 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	07/03/2023
Decision Date	10/03/2023
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