Not Cleared Direct

DEN120023 - GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (FDA 510(k) Clearance)

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

DEN120023 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Jan 2014
Decision
426d
Days
Class 2
Risk

DEN120023 is an FDA 510(k) submission (not cleared) for the GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM. Classified as Colon Capsule Imaging System (product code PGD), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Not Cleared (DENG) decision on January 29, 2014 after a review of 426 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1330 - 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 426 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 Given Imaging , Ltd. devices

Submission Details

510(k) Number DEN120023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 29, 2012
Decision Date January 29, 2014
Days to Decision 426 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
296d slower than avg
Panel avg: 130d · This submission: 426d
Pathway characteristics

Device Classification

Product Code PGD Colon Capsule Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1330
Definition Visualization Of The Colon For The Detection Of Polyps
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.