NaviCam Capsule Endoscope System With NaviCam Stomach Capsule

Magnetically Maneuvered Capsule Endoscopy System

AnX Robotica, Inc.

The following data is part of a De Novo classification by Anx Robotica, Inc. with the FDA for Navicam Capsule Endoscope System With Navicam Stomach Capsule.

Pre-market Notification Details

DeNovo IDDEN190037
Device Name:NaviCam Capsule Endoscope System With NaviCam Stomach Capsule
ClassificationMagnetically Maneuvered Capsule Endoscopy System
Applicant AnX Robotica, Inc. 8 The Green, Ste A Dover,  DE  19901
ContactDavid Duan
Product CodeQKZ  
CFR Regulation Number876.1310 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
Date Received2019-08-13
Decision Date2020-05-22
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00850015518201 DEN190037 000
00850015518195 DEN190037 000
00850015518188 DEN190037 000
00850015518072 DEN190037 000

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