# K243091: Over-tube (TR-1108A)

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Nov 1, 2024 after 32 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)
- K230752: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A), FUJIFILM Healthcare Americas Corporation (2023) Summary page 5.

## 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/K243091
Methodology: https://510kreport.com/methodology