STERILE URETHRAL CATHETERIZATION SET— 510(k) K821978

Name: FDA 510(k) clearance K821978
Creator: U.S. Food and Drug Administration
Published: 1982-08-25

Substantially Equivalent

Medical Devices, Inc.

FDA 510(k) clearance K821978 for STERILE URETHRAL CATHETERIZATION SET, Substantially Equivalent on 1982-08-25. Applicant: Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Medical Devices, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1982-07-06
Decision date: 1982-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.