FDA 510(k)

Pathfinder Endoscope Overtube

Número K: K262262 · 2026-09-18

Data da decisão2026-09-18

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pathfinder Endoscope Overtube 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 2026-09-18 under 510(k) number K262262. 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?

Pathfinder Endoscope Overtube is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K262262.

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

Pathfinder Endoscope Overtube received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262262.

Who is the listed applicant for Pathfinder Endoscope Overtube?

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?

The FDA product code for Pathfinder Endoscope Overtube is FED.

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Fonte oficial

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