Not Cleared Direct

DEN130023 - UROLIFT SYSTEM (FDA 510(k) Clearance)

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

DEN130023 · Neotract, Inc. · Gastroenterology & Urology device
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Sep 2013
Decision
190d
Days
Class 2
Risk

DEN130023 is an FDA 510(k) submission (not cleared) for the UROLIFT SYSTEM. Classified as Implantable Transprostatic Tissue Retractor System (product code PEW), Class II - Special Controls.

Submitted by Neotract, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on September 13, 2013 after a review of 190 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5530 - 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.

View all Neotract, Inc. devices

Submission Details

510(k) Number DEN130023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 07, 2013
Decision Date September 13, 2013
Days to Decision 190 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
60d slower than avg
Panel avg: 130d · This submission: 190d
Pathway characteristics

Device Classification

Product Code PEW Implantable Transprostatic Tissue Retractor System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5530
Definition The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.
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.