# K033203: Wilson-Cook Tri-Tome Select Plus

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Dec 19, 2003 after 78 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). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901443: Zimmon Papillotome, Wilson-Cook Medical, Inc. (1990) Summary page 1.
- K013153: Autotome RX Model # 4515, 4516, Boston Scientific Corp (2001) Summary page 1.

## Most influential descendants
- K052051: Omni Sphincterotome (2005), 4 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K033203
Methodology: https://510kreport.com/methodology