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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K233229
Device Name NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB 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 Number876.1300
Classification Product Code
NEZ  
Subsequent Product Code
QUN  
Date Received09/28/2023
Decision Date 01/05/2024
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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