# K122270: Overtube Endoscopic Access System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Sep 28, 2012 after 60 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: 1 generation back to K040836 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

Source page: https://510kreport.com/device/K122270
Methodology: https://510kreport.com/methodology