FUJIFILM Stiffening Wire Device (SW-2000)— 510(k) K251204

Name: FDA 510(k) clearance K251204
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Substantially Equivalent

FUJIFILM Healthcare Americas Corporation

FDA 510(k) clearance K251204 for FUJIFILM Stiffening Wire Device (SW-2000), Substantially Equivalent on 2025-09-26. Applicant: FUJIFILM Healthcare Americas Corporation. Device class: 2.

Clearance details

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-18
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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.