FDA 510(k)

CONDUIT™ ATP Inserters

Número K: K232014 · 2023-09-01

Data da decisão2023-09-01

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CONDUIT™ ATP Inserters is the device name listed in this FDA 510(k) record. The listed applicant is Enztec Limited. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232014. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CONDUIT™ ATP Inserters?

CONDUIT™ ATP Inserters is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Enztec Limited. The 510(k) number is K232014.

When did CONDUIT™ ATP Inserters receive FDA 510(k) clearance?

CONDUIT™ ATP Inserters received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232014.

Who is the listed applicant for CONDUIT™ ATP Inserters?

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

What is the FDA product code for CONDUIT™ ATP Inserters?

The FDA product code for CONDUIT™ ATP Inserters is MAX.

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Fonte oficial

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