# K232244: Disposable Endoscope Valves System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Endoclean Medical Device Co., Ltd.
- Decided: Nov 29, 2023 after 124 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 10 generations back to K931154 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131780: Evis Exera Iii Video System, Olympus Medical Systems Corp. (2013) Summary page 5.

## Indications for use
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure. Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water. Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction. Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery. Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure. Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel, the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.

Source page: https://510kreport.com/device/K232244
Methodology: https://510kreport.com/methodology