FDA 510(k)

Sistemas de Laminoplastia AQUA

Número K: K252930 · 2026-05-27

RequerenteZheJiang Decans Medical Devices Co., Ltd.

Data da decisão2026-05-27

Código do produtoNQW

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AQUA Laminoplasty Systems is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K252930. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AQUA Laminoplasty Systems?

AQUA Laminoplasty Systems is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K252930.

When did AQUA Laminoplasty Systems receive FDA 510(k) clearance?

AQUA Laminoplasty Systems received FDA 510(k) clearance on 2026-05-27, under 510(k) number K252930.

Who is the listed applicant for AQUA Laminoplasty Systems?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUA Laminoplasty Systems?

The FDA product code for AQUA Laminoplasty Systems is NQW.

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Fonte oficial

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