UroLift System UL400— 510(k) K190377

Substantially Equivalent

Neotract, Inc.

FDA 510(k) clearance K190377 for UroLift System UL400, Substantially Equivalent on 2019-03-21. Applicant: Neotract, Inc..

Clearance details

Applicant: Neotract, Inc.
Product code: Code PEW
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-19
Decision date: 2019-03-21
Decision: Substantially Equivalent
Clearance type: Special
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.