URIHESIVE SYS MALE EXTERNAL CATHETER— 510(k) K842397

Name: FDA 510(k) clearance K842397
Creator: U.S. Food and Drug Administration
Published: 1984-08-08

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K842397 for URIHESIVE SYS MALE EXTERNAL CATHETER, Substantially Equivalent on 1984-08-08. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 2.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-19
Decision date: 1984-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K971929 — AMSINO URINARY LEG BAG1997-08-06

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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.