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SpyGlass DS Direct Visualization System

by Boston Scientific EUDAMED510(k)

Active European Union and United States

510(k) K142922

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142922 Date16 Jan 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

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  • Withdrawn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

Recalls

1 recall · FDA

    • Terminated Z-1133-2018 FDA Class II initiated 20 Dec 2017

    Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FBN
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 SpyGlass DS Direct Visualization System is a flexible/rigid choledochoscope designed for direct visualization of the biliary and pancreatic ducts. It enables diagnostic and therapeutic procedures within the biliary tree, including stone removal, stricture dilation, and biopsy sampling, by providing real-time imaging through an integrated optical system.

This system is supplied as a reusable medical device and is intended for use in gastroenterology and urology procedures. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The device must be sterilized prior to use and is compatible with MRI environments, though specific safety protocols should be followed. Multiple accessory parts are included, each identified by unique registration numbers for traceability and compliance.

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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.

  • Is the SpyGlass DS Direct Visualization System designed for single-use or reusable procedures, and what sterilization requirements apply?

    The SpyGlass DS Direct Visualization System is a reusable medical device, meaning it must be properly sterilized before each use. Since it is intended for repeated procedures, adherence to strict sterilization protocols is essential to ensure patient safety and device integrity. The manufacturer provides guidelines for sterilization, which should be followed to maintain compliance and functionality.

  • What types of procedures can the SpyGlass DS Direct Visualization System be used for within the biliary and pancreatic ducts?

    The SpyGlass DS Direct Visualization System is designed for both diagnostic and therapeutic procedures within the biliary and pancreatic ducts. This includes real-time visualization to aid in stone removal, stricture dilation, and biopsy sampling. Its integrated optical system allows for direct visualization, making it versatile for a range of interventions in gastroenterology and urology.

  • How do I identify the different accessory parts included with the SpyGlass DS Direct Visualization System, and why is this important?

    The SpyGlass DS Direct Visualization System includes multiple accessory parts, each with a unique registration number for traceability and compliance. These numbers help ensure proper inventory management, adherence to regulatory requirements, and accurate tracking for maintenance or replacement. Checking the registration numbers helps confirm the correct accessories are used for each procedure.

  • Can the SpyGlass DS Direct Visualization System be used in an MRI environment, and what precautions should be taken?

    Yes, the SpyGlass DS Direct Visualization System is compatible with MRI environments, but specific safety protocols must be followed to ensure patient and operator safety. Since MRI environments involve strong magnetic fields, it’s critical to verify compatibility with the MRI system in use and follow manufacturer guidelines to avoid interference or risks associated with magnetic fields.

  • What regulatory pathways has the SpyGlass DS Direct Visualization System undergone, and what does this mean for its use in clinical settings?

    The SpyGlass DS Direct Visualization System has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for safety and effectiveness. This means it has undergone rigorous evaluation by regulatory bodies, ensuring it can be used confidently in clinical settings for its intended purposes in gastroenterology and urology procedures. Always refer to the latest regulatory documentation for updates.