FDA 510(k)

Redermax® Antibacterial Wound Matrix

Número K: K261646 · 2026-08-14

RequerenteBeijing Kreate Medical Co., Ltd.

Data da decisão2026-08-14

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Redermax® Antibacterial Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kreate Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K261646. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Redermax® Antibacterial Wound Matrix?

Redermax® Antibacterial Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Beijing Kreate Medical Co., Ltd.. The 510(k) number is K261646.

When did Redermax® Antibacterial Wound Matrix receive FDA 510(k) clearance?

Redermax® Antibacterial Wound Matrix received FDA 510(k) clearance on 2026-08-14, under 510(k) number K261646.

Who is the listed applicant for Redermax® Antibacterial Wound Matrix?

The FDA 510(k) record lists Beijing Kreate Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Redermax® Antibacterial Wound Matrix?

The FDA product code for Redermax® Antibacterial Wound Matrix is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Beijing Kreate Medical Co., Ltd. como candidato(a)

K260020Redermo Wound Matrix K251582Redermax Antibacterial Wound Matrix

Dispositivos Relacionados (Código: FRO)

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