E-Z PEG— 510(k) K921680

Unknown

Mill-Rose Laboratory

FDA 510(k) clearance K921680 for E-Z PEG, Unknown on 1994-05-06. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1992-04-08
Decision date: 1994-05-06
Decision: Unknown
Clearance type: Traditional
Location: Mentor, OH, 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.