# K080050: Spirus Medical Endo-Ease Endoscopic Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Spirus Medical, Inc.
- Decided: May 6, 2008 after 119 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: 4 generations back to K993704 (2000). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060235: Endo-Ease Endoscopic Overtube, Spirus Medical, Inc. (2006) 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

## Indications for use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

Source page: https://510kreport.com/device/K080050
Methodology: https://510kreport.com/methodology