FDA 510(k)

Dual Action Tissue Closure Device

Número K: K250229 · 2025-09-08

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2025-09-08

Código do produtoPKL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dual Action Tissue Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K250229. 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 Dual Action Tissue Closure Device?

Dual Action Tissue Closure Device is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K250229.

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

Dual Action Tissue Closure Device received FDA 510(k) clearance on 2025-09-08, under 510(k) number K250229.

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

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

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

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

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Fonte oficial

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