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Expect Slimline Endoscopic Ultrasound Aspiration Needle

by Boston Scientific

510(k) K133312

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK133312 Date3 Jan 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
ODG
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Expect Slimline Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound system used for sampling targeted submucosal and extramural gastrointestinal lesions through a curvilinear echoendoscope. It is designed for endoscopic ultrasound-guided fine needle aspiration. The device is used in gastroenterology and urology applications.

The Expect Slimline Endoscopic Ultrasound Aspiration Needle is supplied in sizes such as 25ga (0.52mm diameter) and is designed to be used with echoendoscopes with narrow working channels. It features a sharp grind for precise tissue penetration and a highly visible echogenic pattern. The device has received FDA 510K authorization.

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Questions

AI-generated answers, 22 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 Expect Slimline Endoscopic Ultrasound Aspiration Needle used for?

    The Expect Slimline Endoscopic Ultrasound Aspiration Needle is used for endoscopic ultrasound-guided fine needle aspiration of targeted submucosal and extramural gastrointestinal lesions.

  • What sizes is the Expect Slimline Endoscopic Ultrasound Aspiration Needle available in?

    The Expect Slimline Endoscopic Ultrasound Aspiration Needle is available in sizes such as 25ga (0.52mm diameter).

  • What type of echoendoscopes is the Expect Slimline Endoscopic Ultrasound Aspiration Needle designed to be used with?

    The Expect Slimline Endoscopic Ultrasound Aspiration Needle is designed to be used with echoendoscopes with narrow working channels.