# 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

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
- Decided: May 24, 2018 after 261 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 K901443 (1990). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 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 4.

## Most influential descendants
- K201121: Sphincterotome (2021), 2 descendants of its own
- K251104: SureTome™ SW Sphincterotome with DomeTip (2025), 0 descendants of its own
- K232476: Disposable Sphincterotome (2023), 0 descendants of its own
- K222421: Sphincterotome (2023), 0 descendants of its own

## Indications for use
Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASH-ACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II® PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy. Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

Source page: https://510kreport.com/device/K172665
Methodology: https://510kreport.com/methodology