K152580

Substantially Equivalent

rescuenet

Applicant: Endochoice, Inc.
Product code: FDI
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-10
Decision date: 2015-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.