Balloon BS-3— 510(k) K213195

Name: FDA 510(k) clearance K213195
Creator: U.S. Food and Drug Administration
Published: 2021-10-29

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K213195 for Balloon BS-3, Substantially Equivalent on 2021-10-29. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

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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.