# K203350: ENDOtube

- Pathway: 510(k) (Traditional)
- Applicant: Nissha Medical Technologies Sas
- Decided: Sep 29, 2021 after 320 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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 K884836 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 5.
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 5.

## Most influential descendants
- K221310: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (2022), 0 descendants of its own

## Indications for use
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.

Source page: https://510kreport.com/device/K203350
Methodology: https://510kreport.com/methodology