FDA 510(k)

Pathfinder Endoscope Cap

K-Number: K210915 · 2021-05-25

Decision Date2021-05-25

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Pathfinder Endoscope Cap is a medical device manufactured by Neptune Medical, Inc.. It received FDA 510(k) clearance on 2021-05-25 under approval number K210915. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pathfinder Endoscope Cap?

Pathfinder Endoscope Cap is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Neptune Medical, Inc.. The 510(k) number is K210915.

When was Pathfinder Endoscope Cap approved by the FDA?

Pathfinder Endoscope Cap received FDA 510(k) clearance on 2021-05-25, under approval number K210915.

What company makes Pathfinder Endoscope Cap?

Pathfinder Endoscope Cap is manufactured by Neptune Medical, Inc..

What is the FDA product code for Pathfinder Endoscope Cap?

The FDA product code for Pathfinder Endoscope Cap is FDS.

Other Devices by Neptune Medical, Inc.

K191415Pathfinder Endoscope Overtube K211301Pathfinder Endoscope Overtube K230801Pathfinder Endoscope Overtube with Balloon Device K240853Pathfinder® CR System

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Official Source

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