# K201121: Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Feb 5, 2021 after 284 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 K972674 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172665: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords, Wilson-Cook Medical Inc./Cook Endoscopy (2018) Summary page 5.
- K040981: Usw Needleknife Papillotome, Wilson-Cook Medical, Inc. (2004) Summary page 6.

## Most influential descendants
- K232476: Disposable Sphincterotome (2023), 0 descendants of its own
- K222421: Sphincterotome (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K201121
Methodology: https://510kreport.com/methodology