# K251104: SureTome™ SW Sphincterotome with DomeTip

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical
- Decided: Sep 29, 2025 after 171 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: 5 generations back to K970053 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172288: Fusion OMNI Sphincterotome, Wilson-Cook Medical Inc./Cook Endoscopy (2018) Summary page 5.
- 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.

## Indications for use
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Source page: https://510kreport.com/device/K251104
Methodology: https://510kreport.com/methodology