FDA 510(k)

Renasys Edge (66803126)

Número K: K223041 · 2022-11-22

RequerenteSmith & Nephew Medical Limited

Data da decisão2022-11-22

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renasys Edge (66803126) 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 2022-11-22 under 510(k) number K223041. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renasys Edge (66803126)?

Renasys Edge (66803126) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K223041.

When did Renasys Edge (66803126) receive FDA 510(k) clearance?

Renasys Edge (66803126) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K223041.

Who is the listed applicant for Renasys Edge (66803126)?

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 Renasys Edge (66803126)?

The FDA product code for Renasys Edge (66803126) is OMP.

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Dispositivos Relacionados (Código: OMP)

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Fonte oficial

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