Cleared Traditional

K153584 - NeoTract UroLift System UL500 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153584 · Neotract, Inc. · Gastroenterology & Urology device
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Mar 2016
Decision
91d
Days
Class 2
Risk

K153584 is an FDA 510(k) clearance for the NeoTract UroLift System UL500. Classified as Implantable Transprostatic Tissue Retractor System (product code PEW), Class II - Special Controls.

Submitted by Neotract, Inc. (Pleasanton, US). The FDA issued a Cleared decision on March 15, 2016 after a review of 91 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neotract, Inc. devices

Submission Details

510(k) Number K153584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date March 15, 2016
Days to Decision 91 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.