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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetically Maneuvered Capsule Endoscopy System
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 Pkwy.
Plano,  TX  75024
Applicant Contact Tim Thomas
Correspondent
Anx Robotica Corporation
6010 W Spring Creek Pkwy.
Plano,  TX  75024
Correspondent Contact Tim Thomas
Regulation Number876.1310
Classification Product Code
QKZ  
Date Received07/03/2023
Decision Date 10/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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