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Nasal Biliary Drainage Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180868

by Cook Ireland

Identifiers

510(k) Number
K180868 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)

A Nasal Biliary Drainage Set is a device used for biliary drainage, classified under stents, drains and dilators for the biliary ducts. It is substantially equivalent to a predicate device and has received FDA 510(k) clearance under product code FGE and regulation number 876.5010.

The device is intended for use in gastroenterology and urology settings. It is supplied as a set and has been authorized via the FDA 510(k) pathway (K180868) by Cook Ireland, with no indication of sterility, single-use or reusable status, MRI safety, specific sizes, or storage conditions provided in the data.

Frequently asked questions

What is the Nasal Biliary Drainage Set used for?

The Nasal Biliary Drainage Set is used for biliary drainage in gastroenterology and urology settings, as it is classified under stents, drains and dilators for the biliary ducts and is intended to drain bile from the biliary system.

How is the Nasal Biliary Drainage Set supplied?

The device is supplied as a set, meaning it includes all necessary components for biliary drainage procedure, though the specific contents of the set are not detailed in the provided data.

Is the Nasal Biliary Drainage Set sterile or single-use?

The data does not specify whether the Nasal Biliary Drainage Set is sterile, single-use, or reusable, so no determination can be made about its sterility or reuse status from the information provided.

What regulatory pathway was used for the Nasal Biliary Drainage Set?

The Nasal Biliary Drainage Set received FDA 510(k) clearance under the traditional pathway, as indicated by the authorization type FDA_510K and the K-number K180868, showing it was found substantially equivalent to a predicate device.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook Ireland

Sources (1)

  • FDA 510(k) K180868 24 fields · synced Oct 6, 2026