EXPRESSWAY INTERMITTENT CATHETER— 510(k) K061766

Substantially Equivalent

Percutaneous Systems, Incorporated

FDA 510(k) clearance K061766 for EXPRESSWAY INTERMITTENT CATHETER, Substantially Equivalent on 2007-03-09. Applicant: Percutaneous Systems, Incorporated.

Clearance details

Applicant: Percutaneous Systems, Incorporated
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2006-06-22
Decision date: 2007-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.