Cleared Traditional

K173087 - UroLift System (UL400 and UL500) (FDA 510(k) Clearance)

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

K173087 · Neotract, Inc. · Gastroenterology & Urology device
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Dec 2017
Decision
90d
Days
Class 2
Risk

K173087 is an FDA 510(k) clearance for the UroLift System (UL400 and 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 December 28, 2017 after a review of 90 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 K173087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 28, 2017
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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.