CROSSLEAD Standard 035 and CROSSLEAD Stiff 035— 510(k) K261281

Name: FDA 510(k) clearance K261281
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Substantially Equivalent

Filmecc Co., Ltd.

FDA 510(k) clearance K261281 for CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, Substantially Equivalent on 2026-09-03. Applicant: Filmecc Co., Ltd.. Device class: 2.

Clearance details

Applicant: Filmecc Co., Ltd.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2026-04-17
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seto-Shi, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.