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Bard Bilisystem ERCP Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K950700

by C. R. Bard, Inc.

Identifiers

510(k) Number
K950700 FDA 510(k)
FDA Product Code
ODD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Bilisystem ERCP Cannula is an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula, a diagnostic and therapeutic device used in the visualization and cannulation of the biliary and pancreatic ducts during ERCP procedures. It facilitates contrast injection, stone extraction, and stent placement while minimizing trauma to ductal structures.

This cannula is supplied as a single-use, non-sterile device (sterilized prior to use) and is intended for use in endoscopy suites under fluoroscopic guidance. It complies with FDA 510(k) clearance (K950700) under regulation 876.1500, classified as a Class II device under product code ODD. Multiple reference numbers (e.g., 1037905, 1000138054) correspond to its regulatory filings, and it is designed for gastroenterological and urological applications.

Frequently asked questions

Is the Bard Bilisystem ERCP Cannula intended for repeated use in the same patient, or is it designed for single-use only?

The Bard Bilisystem ERCP Cannula is explicitly designed for single-use only. It is supplied in a non-sterile state but is sterilized prior to use, ensuring it remains safe for one-time procedural use in endoscopy suites. Reuse is not recommended or supported by the manufacturer.

What types of procedures is this cannula primarily used for, and how does it assist during those procedures?

This cannula is used during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures, where it aids in visualizing and accessing the biliary and pancreatic ducts. It facilitates key interventions like contrast injection (for imaging), stone extraction, and stent placement while minimizing trauma to delicate ductal structures. Its design supports both diagnostic imaging and therapeutic interventions under fluoroscopic guidance.

How should the Bard Bilisystem ERCP Cannula be stored before use, and are there any special handling requirements?

The cannula is supplied in a non-sterile state but must be sterilized prior to use as part of its single-use workflow. Storage instructions are not explicitly detailed in the provided data, but standard sterile medical device handling practices should apply—keeping it in a clean, dry environment away from direct sunlight or extreme temperatures until sterilization. Always follow the manufacturer’s sterilization protocols (e.g., ethylene oxide or autoclave) to ensure safety and functionality.

What regulatory pathway was followed for FDA clearance of this device, and which advisory committees were involved?

The Bard Bilisystem ERCP Cannula received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device with product code ODD. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, and the device was determined to be substantially equivalent (SESE) to a predicate device. The clearance was granted on April 27, 1995, following a filing received on February 15, 1995.

Are there multiple sizes or models of this cannula available, or is it offered in a single configuration?

The provided data does not specify distinct sizes or models of the Bard Bilisystem ERCP Cannula, nor does it list variations like diameters, lengths, or tip designs. However, the device is referenced under multiple FDA registration numbers (e.g., 1037905, 1000138054), which may correspond to different lot or batch identifiers rather than distinct product variants. For exact sizing or model-specific details, refer to the manufacturer’s current catalog or technical documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (Ercp ..., BARD BILISYSTEM ENDOSCOPIC RETROGRADE… - FDA.report, K950700 FDA 510(k) - BARD BILISYSTEM ENDOSCOPIC RETROGRADE C...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K950700 24 fields · synced Sep 19, 2026