ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007— 510(k) K083153

Unknown

Hollister, Inc.

FDA 510(k) clearance K083153 for ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007, Unknown on 2009-02-04. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2008-10-24
Decision date: 2009-02-04
Decision: Unknown
Clearance type: Traditional
Location: Libertyville, IL, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.