BONASTENT BILIARY— 510(k) K140760

Unknown

Endochoice, Inc.

FDA 510(k) clearance K140760 for BONASTENT BILIARY, Unknown on 2014-06-16. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-26
Decision date: 2014-06-16
Decision: Unknown
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.