UNIVERSAL URETHRAL CATHETER— 510(k) K946282

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K946282 for UNIVERSAL URETHRAL CATHETER, Substantially Equivalent on 1995-03-31. Applicant: Louisville Laboratories, Inc..

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code EZC
Advisory panel: Gastroenterology, Urology
Date received: 1994-12-27
Decision date: 1995-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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Adverse events under product code EZC

product code EZC

Injury: 772
Malfunction: 6,262
Other: 1
Total: 7,035

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.