FDA 510(k)

Disposable Trocars

Número K: K250820 · 2025-07-11

RequerenteSinolinks Medical Innovation, Inc.

Data da decisão2025-07-11

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Trocars is the device name listed in this FDA 510(k) record. The listed applicant is Sinolinks Medical Innovation, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250820. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Trocars?

Disposable Trocars is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Sinolinks Medical Innovation, Inc.. The 510(k) number is K250820.

When did Disposable Trocars receive FDA 510(k) clearance?

Disposable Trocars received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250820.

Who is the listed applicant for Disposable Trocars?

The FDA 510(k) record lists Sinolinks Medical Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Trocars?

The FDA product code for Disposable Trocars is GCJ.

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