FDA 510(k)

XCelliStem Wound Powder

Número K: K172593 · 2018-03-16

Data da decisão2018-03-16

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

XCelliStem Wound Powder is the device name listed in this FDA 510(k) record. The listed applicant is Stemsys. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K172593. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the XCelliStem Wound Powder?

XCelliStem Wound Powder is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Stemsys. The 510(k) number is K172593.

When did XCelliStem Wound Powder receive FDA 510(k) clearance?

XCelliStem Wound Powder received FDA 510(k) clearance on 2018-03-16, under 510(k) number K172593.

Who is the listed applicant for XCelliStem Wound Powder?

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

What is the FDA product code for XCelliStem Wound Powder?

The FDA product code for XCelliStem Wound Powder is KGN.

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Dispositivos Relacionados (Código: KGN)

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Fonte oficial

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