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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K262262
Device Name Pathfinder Endoscope Overtube
Applicant
Neptune Medical, Inc.
1828 El Camino Real
Suite 508
Burlingame,  CA  94010
Applicant Contact Alex Tilson
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
Unit 166
Needham,  MA  02492
Correspondent Contact Keira Jessop
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/02/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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