# K232327: Endorail

- Pathway: 510(k) (Traditional)
- Applicant: Endostart S.R.L.
- Decided: Mar 15, 2024 after 225 days
- Product code: ODC (Endoscope Channel Accessory)
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111760: Naviaid (TM) BGC Device, Smart Medical Systems, Ltd. (2011) Summary page 6.

## Indications for use
ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e., an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.

Source page: https://510kreport.com/device/K232327
Methodology: https://510kreport.com/methodology