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Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

by Boston Scientific

510(k) K202478

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202478↗

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 · Special NumberK202478 Date8 Oct 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1168-2021 FDA Class II initiated 19 Jan 2021

    Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

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  • Withdrawn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
FDI
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.4300
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 Captivator and Captiflex Single-Use Polypectomy Snares are flexible endoscopic snares designed for the removal of polyps during gastrointestinal procedures. These devices fall under the category of flexible snares, intended for use in polypectomy—either cold or hot snare techniques—to excise or biopsy tissue within the digestive tract.

These snares are supplied as single-use, sterile devices and are intended for use in gastroenterology and urology settings. They are classified as Class II medical devices under FDA regulations (876.4300) and have received FDA 510(k) clearance and EU MDR authorisation. Multiple reference codes (e.g., 3006546082, 1037905) identify distinct sizes and variants, ensuring compatibility with various endoscopic systems.

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