FDA 510(k)

REGENETEN™ Bioinductive Implant

Número K: K242631 · 2024-11-26

RequerenteSmith & Nephew Inc., Endoscopy Div.

Data da decisão2024-11-26

Código do produtoOWY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

REGENETEN™ Bioinductive Implant is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242631. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REGENETEN™ Bioinductive Implant?

REGENETEN™ Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K242631.

When did REGENETEN™ Bioinductive Implant receive FDA 510(k) clearance?

REGENETEN™ Bioinductive Implant received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242631.

Who is the listed applicant for REGENETEN™ Bioinductive Implant?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENETEN™ Bioinductive Implant?

The FDA product code for REGENETEN™ Bioinductive Implant is OWY.

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Dispositivos Relacionados (Código: OWY)

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Fonte oficial

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