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Wallstent Biliary Endoprosthesis

by Boston Scientific

510(k) K000308

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)SESU Traditional NumberK000308 Date19 May 2000ClearedStatusActive

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  • Withdrawn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
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 876.5010
Advisory committee
Gastroenterology, Urology
FDA decision
SESU

Overview

AI-generated summary, 27 Sep 2026

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

A Wallstent Biliary Endoprosthesis is a stent, drain, or dilator for the biliary ducts, as defined in the device classification. It is a medical device classified under FDA product code FGE and regulation number 876.5010, intended for use in gastroenterology and urology applications.

The device received FDA 510(k) clearance under K000308 on May 19, 2000, following a traditional review process. It is manufactured by Boston Scientific Corporation in Natick, Massachusetts, and is registered with multiple facility identifier numbers as listed in the OpenFDA data. The device is supplied as a finished product for clinical use in accordance with its authorized indications.

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Questions

AI-generated answers, 27 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 Wallstent Biliary Endoprosthesis used for?

    The Wallstent Biliary Endoprosthesis is intended for use as a stent, drain, or dilator in the biliary ducts, as defined in its device classification, and is applied in gastroenterology and urology procedures to manage biliary drainage or obstruction.

  • How is the Wallstent Biliary Endoprosthesis supplied for clinical use?

    The device is supplied as a finished product for clinical use, meaning it is provided ready for implantation or deployment without requiring additional assembly or sterilization by the user, in accordance with its authorized indications.

  • What regulatory pathway was used for the Wallstent Biliary Endoprosthesis?

    The Wallstent Biliary Endoprosthesis received FDA 510(k) clearance under K000308 on May 19, 2000, following a traditional review process, which indicates it was found substantially equivalent to a legally marketed predicate device.