# K092221: Colonic Splinting Overtube, Model 00711145

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Oct 20, 2009 after 90 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 K853585 (1986). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023259: Inhealth Soft Sleeve Colonoscope Splint, Model CS1200, Helix Medical, Inc. (2002) Summary page 1.
- K052084: Endo-Ease Endoscopic Overtube, Spirus Medical, Inc. (2005) Summary page 1.
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K123013: Endoscopic Introducer (2013), 0 descendants of its own

## Indications for use
The Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.

Source page: https://510kreport.com/device/K092221
Methodology: https://510kreport.com/methodology