# K062805: Modification to Endo-Ease

- Pathway: 510(k) (Special)
- Applicant: Spirus Medical, Inc.
- Decided: Oct 13, 2006 after 24 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 K993704 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052084: Endo-Ease Endoscopic Overtube, Spirus Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K080317: Enolok-for Endoscoped with 12.8>Dia.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>Dia. 11.5MM Shaft ,Model Pel (2008), 0 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/K062805
Methodology: https://510kreport.com/methodology