# K242192: Disposable Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Zksk Technology Co., Ltd.
- Decided: Feb 6, 2025 after 195 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: 2 generations back to K970053 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013153: Autotome RX Model # 4515, 4516, Boston Scientific Corp (2001) Summary page 6.

## Indications for use
The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

Source page: https://510kreport.com/device/K242192
Methodology: https://510kreport.com/methodology