Not Cleared Direct

DEN160014 - remOVE System (FDA 510(k) Clearance)

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

DEN160014 · Ovesco Endoscopy AG · Gastroenterology & Urology device
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Dec 2017
Decision
620d
Days
Class 2
Risk

DEN160014 is an FDA 510(k) submission (not cleared) for the remOVE System. Classified as Endoscopic Electrosurgical Clip Cutting System (product code QAG), Class II - Special Controls.

Submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Not Cleared (DENG) decision on December 22, 2017 after a review of 620 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4310 - 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. High predicate equivalence gap. With 620 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 Ovesco Endoscopy AG devices

Submission Details

510(k) Number DEN160014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 11, 2016
Decision Date December 22, 2017
Days to Decision 620 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
490d slower than avg
Panel avg: 130d · This submission: 620d
Pathway characteristics

Device Classification

Product Code QAG Endoscopic Electrosurgical Clip Cutting System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4310
Definition To Fragment Metallic Clips And Remove Them From The Digestive Tract.
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.