Pathfinder Endoscope Overtube
K-Number: K191415 · 2019-08-30
ApplicantNeptune Medical, Inc.
Decision Date2019-08-30
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Pathfinder Endoscope Overtube is a medical device manufactured by Neptune Medical, Inc.. It received FDA 510(k) clearance on 2019-08-30 under approval number K191415. 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?
Pathfinder Endoscope Overtube is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Neptune Medical, Inc.. The 510(k) number is K191415.
When was Pathfinder Endoscope Overtube approved by the FDA?
Pathfinder Endoscope Overtube received FDA 510(k) clearance on 2019-08-30, under approval number K191415.
What company makes Pathfinder Endoscope Overtube?
Pathfinder Endoscope Overtube is manufactured by Neptune Medical, Inc..
What is the FDA product code for Pathfinder Endoscope Overtube?
The FDA product code for Pathfinder Endoscope Overtube is FED.
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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.