# K182520: Flexible Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Bakelite Co., Ltd.
- Decided: May 15, 2019 after 244 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 4.

## Indications for use
Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

Source page: https://510kreport.com/device/K182520
Methodology: https://510kreport.com/methodology