BONASTENT TRACHEAL / BRONCHIAL— 510(k) K140472

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K140472 for BONASTENT TRACHEAL / BRONCHIAL, Substantially Equivalent on 2014-10-17. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2014-02-25
Decision date: 2014-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCT

product code JCT

Death: 20
Injury: 211
Other: 1
Total: 232

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.