Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)— 510(k) K262214

Name: FDA 510(k) clearance K262214
Creator: U.S. Food and Drug Administration
Published: 2026-10-15

Substantially Equivalent

Guangzhou Aimooe Technology Co., Ltd.

FDA 510(k) clearance K262214 for Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S), Substantially Equivalent on 2026-10-15. Applicant: Guangzhou Aimooe Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Aimooe Technology Co., Ltd.
Product code: Product code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-06-30
Decision date: 2026-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.