# K262262: Pathfinder Endoscope Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Neptune Medical, Inc.
- Decided: Sep 18, 2026 after 78 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K040836 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191415: Pathfinder Endoscope Overtube, Neptune Medical, Inc. (2019) Summary page 5.
- K211301: Pathfinder Endoscope Overtube, Neptune Medical, Inc. (2021) Summary page 5.

## Indications for use
The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

Source page: https://510kreport.com/device/K262262
Methodology: https://510kreport.com/methodology