COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter— 510(k) K180738

Substantially Equivalent

Compactcath, Inc.

FDA 510(k) clearance K180738 for COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter, Substantially Equivalent on 2018-06-14. Applicant: Compactcath, Inc..

Clearance details

Applicant: Compactcath, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2018-03-22
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Palo Alto, 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.