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FDA 510(k)

Pathfinder Endoscope Overtube with Balloon Device

K-Number: K230801 · 2023-07-28

ApplicantNeptune Medical, Inc.
Decision Date2023-07-28
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Neptune Medical, Inc.. The 510(k) number is K230801.

When was Pathfinder Endoscope Overtube with Balloon Device approved by the FDA?

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

What company makes Pathfinder Endoscope Overtube with Balloon Device?

Pathfinder Endoscope Overtube with Balloon Device is manufactured by Neptune Medical, Inc..

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.

Related Clinical Trials

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Other Devices by Neptune Medical, Inc.

K191415Pathfinder Endoscope Overtube K211301Pathfinder Endoscope Overtube K210915Pathfinder Endoscope Cap K240853Pathfinder® CR System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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