510(k) K854580— CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH

Substantially Equivalent

Coloplast A/S

Clearance details

Applicant: Coloplast A/S
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-15
Decision date: 1985-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

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.