Balloon BS-3— 510(k) K213195

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K213195 for Balloon BS-3, Substantially Equivalent on 2021-10-29. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-29
Decision date: 2021-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.