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Interject Injection Therapy Needle Catheter

by Boston Scientific

510(k) K171454

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171454↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK171454 Date7 Jul 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0226-2023 FDA Class II initiated 10 Oct 2022
    • Ongoing Z-0225-2023 FDA Class II initiated 10 Oct 2022

    ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
FBK
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, 18 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 Interject Injection Therapy Needle Catheter is an Endoscopic Injection Needle, classified under the nomenclature for devices used in gastroenterology and urology. It is designed for precise injection therapy, facilitating the delivery of substances such as sclerosing agents, drugs, or contrast media into targeted tissues during endoscopic procedures. Its construction integrates a needle and catheter system to ensure controlled administration while minimizing trauma to surrounding tissues.

This device is intended for single-use in clinical settings and is supplied sterile. It is categorized as a Class II medical device under FDA regulations, with FDA 510K clearance and MDR compliance. Available in various sizes and configurations, it is compatible with standard endoscopic equipment and must be stored according to manufacturer instructions to maintain sterility. No MRI safety information is specified, and its use adheres to regulatory guidelines for endoscopic injection procedures.

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Questions

AI-generated answers, 18 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 types of substances can the Interject Injection Therapy Needle Catheter deliver during endoscopic procedures?

    The Interject Injection Therapy Needle Catheter is designed for the precise delivery of substances such as sclerosing agents, drugs, or contrast media into targeted tissues during endoscopic procedures. Its needle-and-catheter system ensures controlled administration while minimizing trauma to surrounding tissues, making it versatile for various therapeutic or diagnostic injections in gastroenterology and urology.

  • Is the Interject Injection Therapy Needle Catheter reusable, or is it intended for single-use only?

    The Interject Injection Therapy Needle Catheter is explicitly intended for single-use in clinical settings. This design choice ensures sterility and safety for patients, as reuse could compromise integrity and introduce infection risks. Always follow manufacturer instructions for proper disposal after use.

  • How should I store the Interject Injection Therapy Needle Catheter to maintain its sterility?

    The device must be stored according to the manufacturer’s instructions to preserve sterility. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until ready for use, protected from contamination, moisture, and extreme temperatures. Avoid exposing it to direct sunlight or harsh environmental conditions.

  • Are there different sizes or models available for the Interject Injection Therapy Needle Catheter, and how do I choose the right one?

    The Interject Injection Therapy Needle Catheter is available in various sizes and configurations, as indicated by its broad regulatory coverage under product codes like FBK (Gastroenterology-Urology). The correct size depends on the specific endoscopic procedure and anatomical target. Consult the manufacturer’s documentation or a product catalog to match the device to your clinical needs, ensuring compatibility with your endoscopic equipment.

  • Can the Interject Injection Therapy Needle Catheter be used with any standard endoscopic equipment, or are there specific compatibility requirements?

    The device is designed to be compatible with standard endoscopic equipment used in gastroenterology and urology. However, compatibility may depend on the specific model and size selected. Always verify that the chosen Interject catheter integrates seamlessly with your existing endoscopy system to avoid operational issues during procedures. Refer to the manufacturer’s guidelines for detailed compatibility notes.