Not Cleared Direct

DEN190037 - NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190037 · Anx Robotica, Inc. · Gastroenterology & Urology device
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May 2020
Decision
283d
Days
Class 2
Risk

DEN190037 is an FDA 510(k) submission (not cleared) for the NaviCam Capsule Endoscope System with NaviCam Stomach Capsule. Classified as Magnetically Maneuvered Capsule Endoscopy System (product code QKZ), Class II - Special Controls.

Submitted by Anx Robotica, Inc. (Dover, US). The FDA issued a Not Cleared (DENG) decision on May 22, 2020 after a review of 283 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1310 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 283 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Anx Robotica, Inc. devices

Submission Details

510(k) Number DEN190037 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 13, 2019
Decision Date May 22, 2020
Days to Decision 283 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 130d · This submission: 283d
Pathway characteristics

Device Classification

Product Code QKZ Magnetically Maneuvered Capsule Endoscopy System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1310
Definition A Magnetically Maneuvered Capsule Endoscopy System Consists Of An Ingestible Capsule And Magnetic Controller And Is Used For Visualization Of The Stomach And Duodenum. The Ingestible Capsule Contains A Camera That Wirelessly Captures Images Of The Mucosa. The Magnetic Controller Is Used Outside Of The Patient And Is Magnetically Coupled With The Capsule To Control Its Location And Viewing Direction.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.