FDA 510(k)

Sistema AirSeal iFS; Solução AirSeal dV

Número K: K230239 · 2023-09-20

Data da decisão2023-09-20

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirSeal iFS System; AirSeal dV Solution is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K230239. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirSeal iFS System; AirSeal dV Solution?

AirSeal iFS System; AirSeal dV Solution is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Conmed Corporation. The 510(k) number is K230239.

When did AirSeal iFS System; AirSeal dV Solution receive FDA 510(k) clearance?

AirSeal iFS System; AirSeal dV Solution received FDA 510(k) clearance on 2023-09-20, under 510(k) number K230239.

Who is the listed applicant for AirSeal iFS System; AirSeal dV Solution?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirSeal iFS System; AirSeal dV Solution?

The FDA product code for AirSeal iFS System; AirSeal dV Solution is HIF.

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Fonte oficial

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