# K091773: Fujinon Sterile Overtubes

- Pathway: 510(k) (Special)
- Applicant: Fujinon, Inc.
- Decided: Aug 7, 2009 after 52 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 K993704 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 1.
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 1.

## Indications for use
The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

Source page: https://510kreport.com/device/K091773
Methodology: https://510kreport.com/methodology