FDA 510(k)

VERSAJET Hydrosurgery System (III)

Número K: K220964 · 2023-05-16

RequerenteSmith & Nephew Medical Limited

Data da decisão2023-05-16

Código do produtoFQH

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERSAJET Hydrosurgery System (III) 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 2023-05-16 under 510(k) number K220964. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VERSAJET Hydrosurgery System (III)?

VERSAJET Hydrosurgery System (III) is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K220964.

When did VERSAJET Hydrosurgery System (III) receive FDA 510(k) clearance?

VERSAJET Hydrosurgery System (III) received FDA 510(k) clearance on 2023-05-16, under 510(k) number K220964.

Who is the listed applicant for VERSAJET Hydrosurgery System (III)?

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 VERSAJET Hydrosurgery System (III)?

The FDA product code for VERSAJET Hydrosurgery System (III) is FQH.

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Fonte oficial

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