# K080550: Megachannel Endoscopic Overtube, Model OT22

- Pathway: 510(k) (Traditional)
- Applicant: Minos Medical
- Decided: Jun 10, 2008 after 103 days
- Product code: ODB (Endoscopic Contamination Prevention Sheath)
- 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: 1 generation back to K040836 (2004). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K052840: Igi-System, Denx Advanced Dental Systems (2005). Our reading of the summary gave K052840, FDA’s number for Igi-System (Denx Advanced Dental Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Spirus Medical Endo-Ease Overtube”. Kept off the family tree.

## Most influential descendants
- K153698: LumenR Tissue Retractor System (2016), 3 descendants of its own
- K173400: ORISE Tissue Retractor System (2018), 2 descendants of its own
- K182540: DiLumen Endolumenal Interventional Platform (2018), 1 descendant of its own
- K210851: DiLumen Endolumenal Interventional Platform (DiLumen) (2021), 0 descendants of its own

## Indications for use
The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.

Source page: https://510kreport.com/device/K080550
Methodology: https://510kreport.com/methodology