Not Cleared Direct

DEN220006 - ProdiGI (FDA 510(k) Clearance)

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

DEN220006 · Covidien, LLC · Gastroenterology & Urology device
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Jun 2022
Decision
150d
Days
Class 2
Risk

DEN220006 is an FDA 510(k) submission (not cleared) for the ProdiGI. Classified as Endoscopic Traction Device (product code QSW), Class II - Special Controls.

Submitted by Covidien, LLC (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on June 13, 2022 after a review of 150 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4410 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

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Submission Details

510(k) Number DEN220006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 14, 2022
Decision Date June 13, 2022
Days to Decision 150 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
20d slower than avg
Panel avg: 130d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QSW Endoscopic Traction Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4410
Definition An Endoscopic Traction Device Is A Prescription Device That Is Endoscopically Applied To Retract Tissue In The Gastrointestinal Tract During Dissection Procedures To Increase Visualization Of The Dissection Plane And Assist In Tissue Resection, Exposure, And Removal.
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.