# K171989: Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Mar 20, 2018 after 260 days
- Product code: ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K851964 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851964: E.R.C.P.-1 Endoscopic Retrograde Cholangio-Cathete, Wilson-Cook Medical, Inc. (1985) Summary page 4.

## Most influential descendants
- K250573: Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (2025), 0 descendants of its own

## Indications for use
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.

Source page: https://510kreport.com/device/K171989
Methodology: https://510kreport.com/methodology