Product Code: ODD FDA class 2 21 CFR 876.1500

Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Gastroenterology, Urology

The Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula (product code ODD) is a gastroenterology and urology device used during ERCP procedures to cannulate the bile duct or pancreatic duct for the identification of stones, tumors, or narrowings (strictures) in the biliary tree. The cannula is passed through the endoscope's working channel and into the ampulla of Vater. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ODD
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250573	Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M	May 27, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K202583	BioShield biopsy valve EUS - Linear	Nov 06, 2020	Substantially Equivalent	STERIS Corporation
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	Mar 20, 2018	Substantially Equivalent	Wilson-Cook Medical, Inc.
K070420	BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138	Mar 19, 2007	Substantially Equivalent	United States Endoscopy Group, Inc.
K011149	DISPOSABLE BENDING CANNULA PR-233Q	May 15, 2001	Substantially Equivalent	The Olympus Optical Co.
K010993	ALIEN RX MICRO CANNULA, MODEL 4530	Apr 30, 2001	Substantially Equivalent	Boston Scientific Corp
K973205	WILSON-COOK STRICTURE MEASURING CATHETER	Nov 24, 1997	Substantially Equivalent	Wilson-Cook Medical, Inc.
K963051	ERCP CANNULA	Mar 28, 1997	Substantially Equivalent	United States Endoscopy Group, Inc.
K953967	ENDOSCOPIC CATHETER	Jan 22, 1996	Substantially Equivalent	Act Medical, Inc.
K950700	BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA	Apr 27, 1995	Substantially Equivalent	C.R. Bard, Inc.
K950729	OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)	Mar 17, 1995	Substantially Equivalent	Olympus America, Inc.
K910769	SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM	Jun 25, 1991	Substantially Equivalent	Surgitek Medical Engineering Corp.
K884709	ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)	Sep 08, 1989	Substantially Equivalent	Primrose Medical, Inc.
K845018	DAVOL ERCP CANNULA	Jan 15, 1985	Substantially Equivalent	C.R. Bard, Inc.
K834414	ERCP CANNULA	Feb 04, 1984	Substantially Equivalent	Hobbs Medical, Inc.
K833417	ENDOSCOPIC RETROGRADE	Nov 28, 1983	Substantially Equivalent	Microvasive
K820431	E.R.C.P. CANNULAS	Apr 09, 1982	Substantially Equivalent	American Endoscopy, Inc.
K802443	E.R.C.P. CANNULA PRODUCT	Oct 23, 1980	Substantially Equivalent	Mill-Rose Laboratory