FDA 510(k)

Disposable electrosurgical pencil (MD1000)

Número K: K232460 · 2023-10-11

RequerenteShenzhen Mecun Medical Supply Co., Ltd.

Data da decisão2023-10-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable electrosurgical pencil (MD1000) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232460. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable electrosurgical pencil (MD1000)?

Disposable electrosurgical pencil (MD1000) is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. The 510(k) number is K232460.

When did Disposable electrosurgical pencil (MD1000) receive FDA 510(k) clearance?

Disposable electrosurgical pencil (MD1000) received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232460.

Who is the listed applicant for Disposable electrosurgical pencil (MD1000)?

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

What is the FDA product code for Disposable electrosurgical pencil (MD1000)?

The FDA product code for Disposable electrosurgical pencil (MD1000) is GEI.

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Fonte oficial

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