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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 K221608
Device Name NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
Applicant
AnX Robotica Corp
6010 W. Spring Creek Parkway
Plano,  TX  75024
Applicant Contact Tim Thomas
Correspondent
AnX Robotica Corp
6010 W. Spring Creek Parkway
Plano,  TX  75024
Correspondent Contact Tim Thomas
Regulation Number876.1310
Classification Product Code
QKZ  
Date Received06/03/2022
Decision Date 11/22/2022
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
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