LIGHTHOUSE(TM) URINARY CATHETER— 510(k) K131655

Substantially Equivalent

Seedings Life Science Ventures, LLC

FDA 510(k) clearance K131655 for LIGHTHOUSE(TM) URINARY CATHETER, Substantially Equivalent on 2013-11-04. Applicant: Seedings Life Science Ventures, LLC.

Clearance details

Applicant: Seedings Life Science Ventures, LLC
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-06
Decision date: 2013-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.