# K052051: Omni Sphincterotome

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Aug 5, 2005 after 7 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970053 (1997). 4 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K033203: Wilson-Cook Tri-Tome Select Plus, Wilson-Cook Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K172288: Fusion OMNI Sphincterotome (2018), 3 descendants of its own
- 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

## Recalls of this device
- Jun 12, 2009 · Not classified · Z-1598-2009: The wire control port of these devices may be missing due to omission of a manufacturing activity.
- Oct 30, 2008 · Not classified · Z-0325-2009: The wire control port may have been omitted during manufacture.

## Indications for use
Used for cannulation of the ductal system and sphincterotomy.

Source page: https://510kreport.com/device/K052051
Methodology: https://510kreport.com/methodology