UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge— 510(k) K162345

Substantially Equivalent

Neotract, Inc.

FDA 510(k) clearance K162345 for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge, Substantially Equivalent on 2016-09-21. Applicant: Neotract, Inc..

Clearance details

Applicant: Neotract, Inc.
Product code: Code PEW
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-22
Decision date: 2016-09-21
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.