GOOSEN SELF-LUBRICATING CATHETER— 510(k) K923848

Name: FDA 510(k) clearance K923848
Creator: U.S. Food and Drug Administration
Published: 1994-02-18

Substantially Equivalent

Goosen Enterprises, Inc.

FDA 510(k) clearance K923848 for GOOSEN SELF-LUBRICATING CATHETER, Substantially Equivalent on 1994-02-18. Applicant: Goosen Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Goosen Enterprises, Inc.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-07-31
Decision date: 1994-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goldenrod, FL, 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.