510(k) clearances

Pathfinder Endoscope Overtube

Neptune Medical, Inc. · Gastroenterology, Urology

K262262Substantially EquivalentTraditionalFED
Open FDA's page for this record
Third party flag
N
City
Burlingame
Advisory committee description
Gastroenterology, Urology
Address 1
1828 El Camino Real
Address 2
Suite 508
Statement or summary
Summary
Product code
FED
Zip code
94010
Applicant
Neptune Medical, Inc.
Decision date
2026-09-18
Decision code
SESE
Country code
US
Device name
Pathfinder Endoscope Overtube
Advisory committee
GU
Contact
Alex Tilson
K number
K262262
State
CA
Date received
2026-07-02
Review advisory committee
GU
Postal code
94010
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Endoscopic Access Overtube, Gastroenterology-Urology
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3005814162, 8043903, 3045323889, 3021023752, 3014683069, 3013247477, 3005580113, 3032959393, 2431166, 1000121056, 3012797688, 2029275, 3014644276, 1820334, 3010421104, 1647149, 3030733800, 2936485, 3015309643, 3004361445, 9610773, 3030446844, 3042172882, 3002808148, 3009420598, 3016881508, 9611668, 1037955, 3034608931, 8043746, 1018233, 3013944123, 3005941719, 3010273872, 3033589330, 3015225571, 3011050570, 1724474, 1000393132, 3044858680 +77 more
FEI number
3005814162, 3045323889, 3021023752, 3014683069, 3013247477, 3005580113, 3032959393, 3003995201, 1000514656, 1000121056, 3012797688, 1820334, 3010421104, 1000136543, 3030733800, 1000120613, 2936485, 3015309643, 3004361445, 3006149253, 1000122656, 3002807135, 1000160215, 3030446844, 3042172882, 3002806565, 3002808148, 3009420598, 3016881508, 1037955, 3034608931, 1018233, 3013944123, 3002807795, 3002808088, 3010273872, 3033589330, 3015225571, 3002808127, 3011050570 +77 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.