Pathfinder Endoscope Overtube

Endoscopic Access Overtube, Gastroenterology-urology

Neptune Medical, Inc.

The following data is part of a premarket notification filed by Neptune Medical, Inc. with the FDA for Pathfinder Endoscope Overtube.

Pre-market Notification Details

Device IDK211301
510k NumberK211301
Device Name:Pathfinder Endoscope Overtube
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant Neptune Medical, Inc. 1828 El Camino Real Burlingame,  CA  94010
ContactAlex Tilson
CorrespondentIan Broome
AlvaMed, Inc. 935 Great Plain Ave, Ste 166 Needham,  MA  02492
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-29
Decision Date2021-05-28


Device IdentifiersubmissionNumberSupplement
00850006222117 K211301 000
00850006222100 K211301 000
00850006222094 K211301 000
00850006222087 K211301 000
00850006222070 K211301 000

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