# K210934: Sphincterotome / short-wire compatible, Sterile Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Dec 1, 2021 after 247 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 5.

## Indications for use
The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.

Source page: https://510kreport.com/device/K210934
Methodology: https://510kreport.com/methodology