# K230752: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Sep 15, 2023 after 182 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.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- K243091: Over-tube (TR-1108A) (2024), 0 descendants of its own

## Indications for use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

Source page: https://510kreport.com/device/K230752
Methodology: https://510kreport.com/methodology