GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER— 510(k) K140953

Substantially Equivalent

Convatec, Ltd.

FDA 510(k) clearance K140953 for GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER, Substantially Equivalent on 2014-08-01. Applicant: Convatec, Ltd..

Clearance details

Applicant: Convatec, Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-14
Decision date: 2014-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.