# K232476: Disposable Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
- Decided: Nov 7, 2023 after 83 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K972674 (1997). 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)
- K201121: Sphincterotome, Hangzhou AGS MedTech Co., Ltd. (2021) Summary page 5.

## Indications for use
The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K232476
Methodology: https://510kreport.com/methodology