FDA 510(k)

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

Número K: K232163 · 2024-02-22

RequerenteZhejiang Horizon Medical Technology Co., Ltd.

Data da decisão2024-02-22

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K232163. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K232163.

When did Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle receive FDA 510(k) clearance?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle received FDA 510(k) clearance on 2024-02-22, under 510(k) number K232163.

Who is the listed applicant for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

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

What is the FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

The FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is MQE.

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Fonte oficial

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