# K040836: Disposable Overtube

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Jun 10, 2004 after 71 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
No predicates in its family tree.
37 later devices descend from it; 10 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052084: Endo-Ease Endoscopic Overtube (2005), 18 descendants of its own
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K063654: Endoguide (2007), 7 descendants of its own
- K191415: Pathfinder Endoscope Overtube (2019), 6 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own

## Indications for use
The disposable Overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval and/or for endoscopic procedures requiring multiple endoscope intubations.

Source page: https://510kreport.com/device/K040836
Methodology: https://510kreport.com/methodology