K881978

Substantially Equivalent

ENTERAL FEEDING TUBES

Applicant: Primrose Medical, Inc.
Product code: KNT
Advisory panel: Gastroenterology, Urology
Date received: 1988-05-11
Decision date: 1988-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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.