FDA 510(k)

GeniPhys Collymer Self-Assembling Scaffold

Número K: K250329 · 2025-06-25

Data da decisão2025-06-25

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

GeniPhys Collymer Self-Assembling Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Geniphys, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K250329. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GeniPhys Collymer Self-Assembling Scaffold?

GeniPhys Collymer Self-Assembling Scaffold is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Geniphys, Inc.. The 510(k) number is K250329.

When did GeniPhys Collymer Self-Assembling Scaffold receive FDA 510(k) clearance?

GeniPhys Collymer Self-Assembling Scaffold received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250329.

Who is the listed applicant for GeniPhys Collymer Self-Assembling Scaffold?

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

What is the FDA product code for GeniPhys Collymer Self-Assembling Scaffold?

The FDA product code for GeniPhys Collymer Self-Assembling Scaffold is KGN.

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Fonte oficial

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