FDA 510(k)

Phantom XL Insulated Dilators

Número K: K231691 · 2023-06-29

RequerenteTeDan Surgical Innovations, Inc.

Data da decisão2023-06-29

Código do produtoGXZ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phantom XL Insulated Dilators is the device name listed in this FDA 510(k) record. The listed applicant is TeDan Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231691. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phantom XL Insulated Dilators?

Phantom XL Insulated Dilators is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is TeDan Surgical Innovations, Inc.. The 510(k) number is K231691.

When did Phantom XL Insulated Dilators receive FDA 510(k) clearance?

Phantom XL Insulated Dilators received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231691.

Who is the listed applicant for Phantom XL Insulated Dilators?

The FDA 510(k) record lists TeDan Surgical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phantom XL Insulated Dilators?

The FDA product code for Phantom XL Insulated Dilators is GXZ.

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Fonte oficial

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