K852309

Substantially Equivalent

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1

Applicant: Erika, Inc.
Product code: FJK
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-29
Decision date: 1985-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.