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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 K230694
Device Name NaviCam Xpress Stomach System, NaviCam Xpress System
Applicant
Anx Robotica Corp
6010 W Spring Creek Pkwy.
Plano,  TX  75024
Applicant Contact Cathlena Martinez
Correspondent
Anx Robotica Corp
6010 W Spring Creek Pkwy.
Plano,  TX  75024
Correspondent Contact Cathlena Martinez
Regulation Number876.1310
Classification Product Code
QKZ  
Date Received03/13/2023
Decision Date 04/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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