Home / 510(k) Clearances / K171989

510(k) 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 by Wilson-Cook Medical, Inc. — Product Code ODD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2018
Date Received
July 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To identify stones, tumors, or narrowing in the biliary tree.

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  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)

Other clearances for product code ODD

  • K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single (May 27, 2025)
  • K202583 — BioShield biopsy valve EUS - Linear (November 6, 2020)
  • K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (March 19, 2007)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)
  • K010993 — ALIEN RX MICRO CANNULA, MODEL 4530 (April 30, 2001)
  • K973205 — WILSON-COOK STRICTURE MEASURING CATHETER (November 24, 1997)
  • K963051 — ERCP CANNULA (March 28, 1997)
  • K953967 — ENDOSCOPIC CATHETER (January 22, 1996)
  • K950700 — BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA (April 27, 1995)
  • K950729 — OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) (March 17, 1995)