# K040981: Usw Needleknife Papillotome

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: May 7, 2004 after 22 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: 1 generation back to K972674 (1997). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972674: Wilson-Cook Needle Knife Papillotome, Wilson-Cook Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K201121: Sphincterotome (2021), 2 descendants of its own
- K232476: Disposable Sphincterotome (2023), 0 descendants of its own
- K222421: Sphincterotome (2023), 0 descendants of its own

## Indications for use
The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K040981
Methodology: https://510kreport.com/methodology