FDA 510(k) Application Details - K241934

Device Classification Name	More FDA Info for this Device
510(K) Number	K241934
Device Name	NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
Applicant	AnX Robotica Corp. 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	07/02/2024
Decision Date	07/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review