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Wiltek Nasal Biliary Drainage Set

by Wiltek Medical, Inc.

510(k) K894870

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894870 Date21 Dec 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BSS
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wiltek Nasobiliary Drainage Set is a medical device used for biliary drainage procedures. It is designed to facilitate drainage from the biliary tract through a nasal route, providing a pathway for bile to exit the body when normal flow is obstructed.

This device is supplied as a single-use or reusable product depending on the specific configuration, though the sterility status is not specified in the provided data. It is intended for use in gastroenterology and urology procedures and has been cleared by the FDA under 510(k) K894870 as substantially equivalent. The device is available in various sizes and configurations, though specific measurements are not provided in the data.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Wiltek Nasobiliary Drainage Set used for?

    The Wiltek Nasobiliary Drainage Set is a medical device designed for biliary drainage procedures. It creates a pathway for bile to exit the body through a nasal route when normal bile flow is obstructed, primarily used in gastroenterology and urology procedures.

  • Is the Wiltek Nasobiliary Drainage Set single-use or reusable?

    The Wiltek Nasobiliary Drainage Set is supplied as either a single-use or reusable product depending on the specific configuration selected. The sterility status is not specified in the provided data.

  • What sizes and configurations are available for the Wiltek Nasobiliary Drainage Set?

    The Wiltek Nasobiliary Drainage Set is available in various sizes and configurations to accommodate different clinical needs. However, specific measurements are not provided in the device data.

  • What is the regulatory status of the Wiltek Nasobiliary Drainage Set?

    The Wiltek Nasobiliary Drainage Set has been cleared by the FDA under 510(k) K894870 as substantially equivalent. It is classified as a Class 2 device with product code BSS and is intended for use in gastroenterology and urology procedures.