NeoTract UroLift System UL500— 510(k) K153584

Name: FDA 510(k) clearance K153584
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Substantially Equivalent

Neotract, Inc.

FDA 510(k) clearance K153584 for NeoTract UroLift System UL500, Substantially Equivalent on 2016-03-15. Applicant: Neotract, Inc.. Device class: 2.

Clearance details

Applicant: Neotract, Inc.
Product code: Code PEW
Device class: Class 2
Regulation: 21 CFR 876.5530
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-15
Decision date: 2016-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K200441 — UroLift Advanced Tissue Control (ATC) System2020-06-05
K193269 — UroLift System (UL400)2019-12-20
K190377 — UroLift System UL4002019-03-21

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K173087 — UroLift System (UL400 and UL500)2017-12-28
K172359 — UroLift System (UL500)2017-08-18
K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge2016-09-21

Adverse events under product code PEW

product code PEW

Death: 7
Injury: 161
Total: 168

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.