# K251204: FUJIFILM Stiffening Wire Device (SW-2000)

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Sep 26, 2025 after 161 days
- Product code: FDA (Enteroscope And Accessories)
- 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 K931650 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051068: Zutron Colonoscope Stiffening Device, Zutron Medical (2005) Summary page 5.

## Indications for use
The intended use of the device is to allow the physician to increase the stiffness of the enteroscope when additional rigidity is required. Do not use this product for any other purposes.

Source page: https://510kreport.com/device/K251204
Methodology: https://510kreport.com/methodology