# K023259: Inhealth Soft Sleeve Colonoscope Splint, Model CS1200

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, Inc.
- Decided: Dec 26, 2002 after 87 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: 2 generations back to K853585 (1986). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 1.
- (no number) Pentax Splinting Tube: named in the summary without a submission number
- (no number) ACMI Splinting Tube: named in the summary without a submission number

## Most influential descendants
- K092221: Colonic Splinting Overtube, Model 00711145 (2009), 5 descendants of its own
- K100081: Enteroscopy Overtube, Model 00712140 (2010), 3 descendants of its own
- K110531: Endoflip Ecd (2011), 1 descendant of its own
- K192691: PatCom Single-Use Introducer (2020), 0 descendants of its own
- K150083: Sidecar External Working Channel (2015), 0 descendants of its own

## Indications for use
The InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.

Source page: https://510kreport.com/device/K023259
Methodology: https://510kreport.com/methodology