ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S— 510(k) K021493

Substantially Equivalent

Andersen Products, Inc.

FDA 510(k) clearance K021493 for ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S, Substantially Equivalent on 2002-08-30. Applicant: Andersen Products, Inc..

Clearance details

Applicant: Andersen Products, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2002-05-09
Decision date: 2002-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Haw River, NC, 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.