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Wiltek Biliary Stent Set

by Wiltek Medical, Inc.

510(k) K894871

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 NumberK894871 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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 Biliary Stent Set is a device classified as Stents, Drains And Dilators For The Biliary Ducts. It received FDA 510(k) clearance under K894871 on December 21, 1989, and is substantially equivalent to a predicate device. The device is intended for use in gastroenterology and urology applications.

Manufactured by Wiltek Medical, Inc., the device is supplied as a set and is regulated under product code FGE and regulation number 876.5010. It is a Class II medical device with no indication of sterility, single-use or reusable status, MRI safety, specific sizes, or storage conditions provided in the data. The authorization is based on traditional 510(k) submission review.

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Questions

AI-generated answers, 1 Oct 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 Biliary Stent Set intended for?

    The Wiltek Biliary Stent Set is intended for use in gastroenterology and urology applications, specifically as stents, drains, and dilators for the biliary ducts, based on its FDA 510(k) clearance and product classification.

  • How is the Wiltek Biliary Stent Set supplied and what is its regulatory classification?

    The device is supplied as a set and is regulated under product code FGE and regulation number 876.5010 as a Class II medical device, with clearance obtained through a traditional 510(k) submission process.

  • What is the FDA 510(k) number and clearance date for the Wiltek Biliary Stent Set?

    The Wiltek Biliary Stent Set received FDA 510(k) clearance under K894871 on December 21, 1989, and was determined to be substantially equivalent to a predicate device.