510(k) Report

510(k) · Cleared

Cleared

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

K171989510(k) TraditionalCleared Mar 20, 2018260-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Cleared on Mar 20, 2018 as substantially equivalent to K851964 (Wilson-Cook Medical, Inc., 1985) after a 260-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided
Mar 20, 2018
Review
260 days
Class
Class II
Product code
ODD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K851964 (1985). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant clearedK851964 · E.R.C.P.-1 Endoscopic Retrograde Cholangio-Cathete · Wilson-Cook Medical, Inc. · 19851990200020102020
Descendants, by generation 1 generation forward: 1 descendant K851964 · E.R.C.P.-1 Endoscopic Retrograde Cholangio-Cathete · Wilson-Cook Medical, Inc. · 19850
  1. Root · 1 generation backK851964 E.R.C.P.-1 Endoscopic Retrograde Cholangio-CatheteWilson-Cook Medical, Inc. · 1985
  2. This deviceK171989 Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and…Wilson-Cook Medical, Inc. · 2018
  3. Descendant · cites it directly · 0 of its ownK250573 Single Use Cannula V…Olympus Medical Systems Corp. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use…Olympus Medical Systems Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851964E.R.C.P.-1 Endoscopic Retrograde Cholangio-CatheteWilson-Cook Medical, Inc.1985—
0 (this device)K171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon…Wilson-Cook Medical, Inc.2018—
+1K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q…Olympus Medical Systems Corp.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K171989, 1985–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ODD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ODD device

  1. #1 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K851964E.R.C.P.-1 Endoscopic Retrograde Cholangio-Cathete
Summary page 4
…ation Name: Endoscope and accessories Predicate Device: Endoscopic Retrograde Cholangiography Catheter (E.R.C.P); K851964, cleared June 13, 1985 Intended Use This device is used for endoscopic cannulation of the ductal system. This device is indicat…
Wilson-Cook Medical, Inc.1985—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use…Olympus Medical Systems Corp.20250

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K250573 (Olympus Medical Systems Corp., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ODD devices

ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · ODD

1in 2025

2007: 12018: 12020: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODD

Too few ODD 510(k)s in any year since 2007 to give a median.

Recalls per year · ODD

No recall names ODD since 2007.

Adverse event reports per year · ODD

4in 2025

2007: 12008: 92009: 262012: 22015: 12016: 22017: 22018: 132019: 52020: 112021: 82022: 112023: 152024: 122025: 4
2007high 26 (2009) · low 0 (2010)2025

MAUDE reports naming product code ODD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—09
20090—026
20100—00
20110—00
20120—02
20130—00
20140—00
20150—01
20160—02
20170—02
20181—013
20190—05
20201—011
20210—08
20220—011
20230—015
20240—012
20251—04
20260—0—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in ODD

The ODD category page

  • K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp. · 2025
  • K202583BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020
  • K070420Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 20071 recall
  • K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
  • K010993Alien RX Micro Cannula, Model 4530Boston Scientific Corp · 2001

https://510kreport.com/device/K171989 · printed Nov 5, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171989

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026