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Biliary Balloon Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K863571

by Uresil Corp.

Identifiers

510(k) Number
K863571 FDA 510(k)
FDA Product Code
FGE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5010 FDA 510(k)
Regulation Number
876.5010 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Stent, Drain, and Dilator for the Biliary Ducts, classified under FDA product code FGE. It is designed as a balloon catheter used for mechanical dilation of biliary strictures or obstructions, facilitating the restoration of bile flow through the bile ducts. The device incorporates an inflatable balloon to expand the narrowed ductal lumen, aiding in the placement of stents or drainage catheters.

The Biliary Balloon Catheter is supplied as a single-use, non-sterile device (unless terminally sterilized per packaging instructions) and is intended for use in interventional radiology or endoscopy settings. It is available in various sizes, including diameters ranging from 8F to 16F, with radiopaque markers for fluoroscopic guidance. Compliance with FDA 510(k) clearance (K863571) and regulation 876.5010 ensures its regulatory standing. Sterilization and storage instructions must be followed as specified in the accompanying documentation.

Frequently asked questions

What is the Uresil Biliary Balloon Catheter used for?

The Uresil Biliary Balloon Catheter is designed to mechanically dilate narrowed or obstructed bile ducts (strictures) during interventional radiology or endoscopic procedures. By inflating the balloon within the duct, it expands the lumen, allowing for easier placement of stents or drainage catheters to restore bile flow.

Is the Biliary Balloon Catheter single-use or reusable?

This device is supplied as a single-use catheter. It is intended for one-time use per patient to ensure safety and sterility. Reuse is not recommended unless explicitly stated in updated packaging or manufacturer instructions.

What sizes are available for the Biliary Balloon Catheter?

The catheter is available in multiple French (F) sizes, ranging from 8F to 16F, to accommodate different patient anatomies and clinical needs. The size selection depends on the duct diameter and the specific dilation requirements.

How should the Biliary Balloon Catheter be stored?

Storage instructions are detailed in the accompanying documentation. Generally, the device should be kept in a clean, dry environment away from direct sunlight and extreme temperatures. If terminally sterilized, follow the sterilization validation protocols provided by Uresil Corp. to maintain integrity.

Does the Biliary Balloon Catheter include radiopaque markers?

Yes, the catheter incorporates radiopaque markers to ensure visibility under fluoroscopy. This feature aids clinicians in precise placement and dilation during procedures, reducing the risk of misalignment or complications.

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: BILIARY BALLOON CATHETER (K863571) — FDA 510 (k) | Innolitics, Uresil - medical device development, Chole-Cath Biliary Drainage Catheter - Uresil, PDF K863571 BILIARY BALLOON CATHETER - 510kdatabase.net, Uresil Corp. FDA 510 (k) Products (1981-2001)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Uresil Corp.

Sources (1)

  • FDA 510(k) K863571 24 fields · synced Oct 1, 2026