UROLIFT SYSTEM— 510(k) DEN130023

Unknown

Neotract, Inc.

FDA 510(k) clearance DEN130023 for UROLIFT SYSTEM, Unknown on 2013-09-13. Applicant: Neotract, Inc..

Clearance details

Applicant: Neotract, Inc.
Product code: Code PEW
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-07
Decision date: 2013-09-13
Decision: Unknown
Clearance type: Direct
Location: Pleasanton, CA, US

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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.