NeoTract UroLift System UL500— 510(k) K153584

Substantially Equivalent

Neotract, Inc.

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

Clearance details

Applicant: Neotract, Inc.
Product code: Code PEW
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 ↗

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.