# K221310: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Endoclean Medical Device Co., Ltd.
- Decided: Oct 7, 2022 after 155 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: 4 generations back to K884836 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203350: ENDOtube, Nissha Medical Technologies Sas (2021) Summary page 5.

## Indications for use
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o 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. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile. Irrigation Tube The Irrigation Tube (tube and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. Clean Cap Clean cap is intended to be used with an air or CO2 source and / or pump along with a sterile water source to supply air or CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures. Clean Cap with CO2 Source Tube Clean cap with CO2 source tube is intended to be used with CO2 source along with a sterile water source to supply CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures. Hybrid Irrigation Tubing The Hybrid irrigation tubing (tubing and accessories to accommodate various Gl endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump. Hybrid Irrigation Tubing With CO2 source tube The Hybrid Irrigation Tubing with CO2 Source Tube (tubing and accessories to accommodate various GI endoscopes, irrigation pumps and CO2 source) is intended to provide irrigation via sterile water when used in conjunction with an irrigation pump, and to supply CO2 along with sterile water during GI endoscopic procedures. Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a Gl endoscope during GI endoscopic procedures.

Source page: https://510kreport.com/device/K221310
Methodology: https://510kreport.com/methodology