# K052084: Endo-Ease Endoscopic Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Spirus Medical, Inc.
- Decided: Sep 14, 2005 after 43 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: 2 generations back to K993704 (2000). 4 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 1.
- K973500: Bard Endoscopic Overtube (#000307), C.R. Bard, Inc. (1997) Summary page 1.
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Most influential descendants
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K092221: Colonic Splinting Overtube, Model 00711145 (2009), 5 descendants of its own
- K060235: Endo-Ease Endoscopic Overtube (2006), 5 descendants of its own

## Indications for use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.

Source page: https://510kreport.com/device/K052084
Methodology: https://510kreport.com/methodology