DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE— 510(k) K012147

Substantially Equivalent

Zevex, Inc.

FDA 510(k) clearance K012147 for DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE, Substantially Equivalent on 2001-11-02. Applicant: Zevex, Inc..

Clearance details

Applicant: Zevex, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-10
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, 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.