ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)— 510(k) K011077

Substantially Equivalent

Andersen Products, Inc.

FDA 510(k) clearance K011077 for ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22), Substantially Equivalent on 2001-05-09. Applicant: Andersen Products, Inc..

Clearance details

Applicant: Andersen Products, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-09
Decision date: 2001-05-09
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.