# K210915: Pathfinder Endoscope Cap

- Pathway: 510(k) (Traditional)
- Applicant: Neptune Medical, Inc.
- Decided: May 25, 2021 after 57 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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: 5 generations back to K993704 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR, Fujifilm Medical Systems U.S.A, Inc. (2017) Summary page 4.

## Indications for use
The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

Source page: https://510kreport.com/device/K210915
Methodology: https://510kreport.com/methodology