# K173758: Disposable Biopsy Valve

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: May 14, 2018 after 154 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 K111821 (2011). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142068: Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile, Medovations, Inc. (2015) Summary page 4.
- K161167: Seal Single-Use Biopsy Valve, Endochoice, Inc. (2016) Summary page 4.

## Indications for use
The Disposable Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K173758
Methodology: https://510kreport.com/methodology