FDA 510(k)

LUOFUCON® Wound Matrix

Número K: K254256 · 2026-08-18

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2026-08-18

Código do produtoQSZ

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUOFUCON® Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K254256. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LUOFUCON® Wound Matrix?

LUOFUCON® Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K254256.

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

LUOFUCON® Wound Matrix received FDA 510(k) clearance on 2026-08-18, under 510(k) number K254256.

Who is the listed applicant for LUOFUCON® Wound Matrix?

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

What is the FDA product code for LUOFUCON® Wound Matrix?

The FDA product code for LUOFUCON® Wound Matrix is QSZ.

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Outros registros que listam Huizhou Foryou Medical Devices Co., Ltd. como candidato(a)

K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen Dressing K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

Ver todos os 18 dispositivos →

Dispositivos Relacionados (Código: QSZ)

K261311HYALOMATRIXAnika Therapeutics, Inc.K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® Wound MatrixSioxmed, LLC K232847SiOxD Wound MatrixSioxmed, LLC

Fonte oficial

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