FDA 510(k)

Pathfinder Endoscope Overtube with Balloon Device

Número K: K230801 · 2023-07-28

Data da decisão2023-07-28

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pathfinder Endoscope Overtube with Balloon Device is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K230801. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pathfinder Endoscope Overtube with Balloon Device?

Pathfinder Endoscope Overtube with Balloon Device is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K230801.

When did Pathfinder Endoscope Overtube with Balloon Device receive FDA 510(k) clearance?

Pathfinder Endoscope Overtube with Balloon Device received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230801.

Who is the listed applicant for Pathfinder Endoscope Overtube with Balloon Device?

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

What is the FDA product code for Pathfinder Endoscope Overtube with Balloon Device?

The FDA product code for Pathfinder Endoscope Overtube with Balloon Device is FED.

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Dispositivos Relacionados (Código: FED)

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Fonte oficial

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