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FDA 510(k)

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)

K-Number: K262214 · 2026-10-15

ApplicantGuangzhou Aimooe Technology Co., Ltd.
Decision Date2026-10-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Aimooe Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K262214. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)?

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Guangzhou Aimooe Technology Co., Ltd.. The 510(k) number is K262214.

When did Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) receive FDA 510(k) clearance?

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) received FDA 510(k) clearance on 2026-10-15, under 510(k) number K262214.

Who is the listed applicant for Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)?

The FDA 510(k) record lists Guangzhou Aimooe Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)?

The FDA product code for Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) is HAW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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