FDA 510(k)

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

Número K: K242146 · 2024-12-17

RequerenteSmith & Nephew Medical Limited

Data da decisão2024-12-17

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K242146. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K242146.

When did BIOBRANE Temporary Wound Dressing; BIOBRANE Glove receive FDA 510(k) clearance?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242146.

Who is the listed applicant for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

The FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is KGN.

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Fonte oficial

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