Not Cleared Direct

EndoRotor Device (DEN200016) - FDA 510(k) Clearance

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

DEN200016 · Interscope, Inc. · Gastroenterology & Urology device
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Dec 2020
Decision
282d
Days
Class 2
Risk

DEN200016 is an FDA 510(k) submission (not cleared) for the EndoRotor Device. Classified as Endoscopic Pancreatic Debridement Device (product code QNE), Class II - Special Controls.

Submitted by Interscope, Inc. (Whitinsville, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2020 after a review of 282 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4330 - 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 282 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 Interscope, Inc. devices

Submission Details

510(k) Number DEN200016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 16, 2020
Decision Date December 23, 2020
Days to Decision 282 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
152d slower than avg
Panel avg: 130d · This submission: 282d
Pathway characteristics

Device Classification

Product Code QNE Endoscopic Pancreatic Debridement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4330
Definition An Endoscopic Pancreatic Debridement Device Is Inserted Via An Endoscope And Placed Through A Cystogastrostomy Fistula Into The Pancreatic Cavity. It Is Intended For Removal Of Necrotic Tissue From A Walled Off Pancreatic Necrosis (wopn) Cavity.
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.