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Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

by Boston Scientific 2 variants

510(k) K173184

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 NumberK173184 Date27 Oct 2017ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 (SL) Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound aspiration needle designed to sample targeted submucosal and extramural gastrointestinal lesions. It is intended to be coupled to the biopsy channel of a curvilinear array echoendoscope to facilitate diagnostic and therapeutic procedures within the digestive tract.

This device connects via a standard luer connection and is delivered into the digestive tract through the accessory channel of an echoendoscope. It is regulated under FDA 510(k) clearance number K173184.

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Questions

AI-generated answers, 26 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 primary purpose of the Expect Slimline SL needle?

    This device is designed to sample targeted submucosal and extramural gastrointestinal lesions. It is intended to be used during diagnostic and therapeutic procedures within the digestive tract.

  • How is the needle connected to the endoscopic equipment?

    The device features a standard luer connection, which allows it to be coupled to the biopsy channel of a curvilinear array echoendoscope for use during procedures.

  • How is the device delivered into the digestive tract?

    The needle is delivered into the digestive tract by passing it through the accessory channel of a compatible echoendoscope.

  • What is the regulatory status of this device?

    The Expect Slimline SL Endoscopic Ultrasound Aspiration Needle is regulated under FDA 510(k) clearance number K173184.