# K172288: Fusion OMNI Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
- Decided: Apr 17, 2018 after 260 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: 4 generations back to K970053 (1997). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052051: Omni Sphincterotome, Wilson-Cook Medical, Inc. (2005) Summary page 4.

## Most influential descendants
- K192339: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (2020), 1 descendant of its own
- K251104: SureTome™ SW Sphincterotome with DomeTip (2025), 0 descendants of its own
- K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (2025), 0 descendants of its own

## 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/K172288
Methodology: https://510kreport.com/methodology