ClearanceBrief
510(k) K262214 ยท HAW Neurological Stereotaxic Instrument

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

ApplicantGuangzhou Aimooe Technology Co., Ltd., Guangzhou, CN
DecisionSubstantially Equivalent, Oct 15, 2026
ReceivedJun 30, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262214

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.