Cleared Special

K190377 - UroLift System UL400 (FDA 510(k) Clearance)

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

K190377 · Neotract, Inc. · Gastroenterology & Urology device
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Mar 2019
Decision
30d
Days
Class 2
Risk

K190377 is an FDA 510(k) clearance for the UroLift System UL400. 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 21, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5530 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neotract, Inc. devices

Submission Details

510(k) Number K190377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date March 21, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.