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SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

by Boston Scientific

510(k) K183636

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183636↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK183636 Date22 Jan 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
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 SpyScope DS and SpyScope DS II Access and Delivery Catheters, along with the SpyGlass DS Digital Controller, are flexible choledochoscopes designed for direct visualization of the biliary and pancreatic ducts. These devices enable diagnostic and therapeutic interventions, including stone removal, stricture management, and tissue inspection during procedures such as ERCP (Endoscopic Retrograde Cholangiopancreatography).

The SpyScope catheters are supplied as single-use devices and are intended for use in controlled clinical settings such as endoscopy suites. They are compatible with a range of diagnostic and therapeutic accessories and are regulated under FDA 510(k) clearance and MDR. The SpyGlass DS Digital Controller integrates with the catheter system for enhanced imaging and procedural guidance, adhering to MRI-safe standards where applicable. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.

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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.

  • Are the SpyScope DS catheters reusable or single-use, and how should they be stored to maintain integrity?

    The SpyScope DS and SpyScope DS II Access and Delivery Catheters are single-use devices, designed for controlled clinical settings like endoscopy suites. To preserve sterility and functionality, storage must follow Boston Scientific’s manufacturer guidelines, which likely include keeping them in sealed packaging until use and avoiding exposure to moisture, extreme temperatures, or physical damage.

  • What types of procedures can the SpyGlass DS Digital Controller assist with, and how does it integrate with the catheter system?

    The SpyGlass DS Digital Controller is paired with the SpyScope DS catheters to provide enhanced imaging and procedural guidance during ERCP (Endoscopic Retrograde Cholangiopancreatography) and related interventions. It enables real-time visualization of the biliary and pancreatic ducts, facilitating diagnostic tasks like stone removal, stricture management, and tissue inspection. The controller adheres to MRI-safe standards where applicable, ensuring compatibility with imaging environments.

  • What regulatory pathways have the SpyScope DS system undergone, and which committees were involved in its review?

    The SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, and SpyGlass DS Digital Controller have been cleared under the FDA 510(k) pathway (K183636) and comply with the EU Medical Device Regulation (MDR). The device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, with a decision classified as *Substantially Equivalent* (SESE). The product code assigned is FBN, reflecting its classification as a Class II device.

  • What accessories or tools are compatible with the SpyScope DS catheters for therapeutic interventions?

    The SpyScope DS and DS II catheters are designed to be compatible with a range of diagnostic and therapeutic accessories used in ERCP procedures. While the exact accessories aren’t listed, typical compatible tools may include biopsy forceps, lithotripsy devices for stone fragmentation, dilation catheters for stricture management, and retrieval baskets for stone extraction. Always verify compatibility with Boston Scientific’s current documentation for your specific model.