# K211301: Pathfinder Endoscope Overtube

- Pathway: 510(k) (Special)
- Applicant: Neptune Medical, Inc.
- Decided: May 28, 2021 after 29 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: 3 generations back to K040836 (2004). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 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 4.

## Most influential descendants
- K262262: Pathfinder Endoscope Overtube (2026), 0 descendants of its own
- K240853: Pathfinder® CR System (2024), 0 descendants of its own
- K230801: Pathfinder Endoscope Overtube with Balloon Device (2023), 0 descendants of its own

## 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/K211301
Methodology: https://510kreport.com/methodology