FDA 510(k)

Disposable Dual Action Tissue Closure Device

Número K: K233772 · 2024-03-19

RequerenteMirco-Tech (Nanjing) Co., Ltd.

Data da decisão2024-03-19

Código do produtoPKL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Dual Action Tissue Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K233772. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Dual Action Tissue Closure Device?

Disposable Dual Action Tissue Closure Device is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K233772.

When did Disposable Dual Action Tissue Closure Device receive FDA 510(k) clearance?

Disposable Dual Action Tissue Closure Device received FDA 510(k) clearance on 2024-03-19, under 510(k) number K233772.

Who is the listed applicant for Disposable Dual Action Tissue Closure Device?

The FDA 510(k) record lists Mirco-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Dual Action Tissue Closure Device?

The FDA product code for Disposable Dual Action Tissue Closure Device is PKL.

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Dispositivos Relacionados (Código: PKL)

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Fonte oficial

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