# K051068: Zutron Colonoscope Stiffening Device

- Pathway: 510(k) (Traditional)
- Applicant: Zutron Medical
- Decided: Jul 11, 2005 after 76 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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 K931650 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901610: Sullivan Variable Stiffness Cable, Wilson-Cook Medical, Inc. (1990) Summary page 1.
- K941973: Gip/Medi-Globe Guide Wires & Wind-UP Guide Wires, Medi-Globe Corp. (1995) Summary page 1.
- K023603: Endo-Glide Guidewire, Endo-Therapeutics, Inc. (2003) Summary page 1.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 1.
- (no number) Steel Wire: named in the summary without a submission number
- (no number) GIP / Medi-Globe, Stiffy Variable Stiffness Guide Wire: named in the summary without a submission number

## Most influential descendants
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (2025), 0 descendants of its own

## Indications for use
The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.

Source page: https://510kreport.com/device/K051068
Methodology: https://510kreport.com/methodology