INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT— 510(k) K013483

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K013483 for INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT, Substantially Equivalent on 2002-01-14. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2001-10-19
Decision date: 2002-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

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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.