CompactCath Intermittent Urinary Catheter— 510(k) K160858

Name: FDA 510(k) clearance K160858
Creator: U.S. Food and Drug Administration
Published: 2016-04-26

Substantially Equivalent

Compactcath, Inc.

FDA 510(k) clearance K160858 for CompactCath Intermittent Urinary Catheter, Substantially Equivalent on 2016-04-26. Applicant: Compactcath, Inc.. Device class: 2.

Clearance details

Applicant: Compactcath, Inc.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-29
Decision date: 2016-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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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.