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AutoCap RX

by Boston Scientific

510(k) K210353

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210353↗

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 NumberK210353 Date6 May 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
ODC
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 AutoCap RX is an Endoscope Channel Accessory designed for securing guidewires and facilitating device exchanges during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. It provides a secure attachment to the endoscope while minimizing leakage of biomaterial and maintaining insufflation, ensuring stable guidewire placement.

Supplied as a reusable device, the AutoCap RX is compatible with 0.035-inch (0.90 mm) and 0.025-inch (0.63 mm) guidewires. It is intended for use in clinical settings where ERCP procedures are performed, adhering to regulatory standards including FDA 510K clearance and MDR compliance. Storage and handling follow manufacturer guidelines to maintain functionality and sterility where applicable.

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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 is the AutoCap RX used for during ERCP procedures and how does it improve the workflow?

    The AutoCap RX is designed to securely attach guidewires to the endoscope during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. It helps stabilize guidewire placement while minimizing leakage of biomaterial and maintaining insufflation, which reduces disruptions and improves the efficiency of device exchanges.

  • Is the AutoCap RX compatible with specific guidewire sizes, and if so, which ones?

    Yes, the AutoCap RX is specifically compatible with two common guidewire sizes: 0.035-inch (0.90 mm) and 0.025-inch (0.63 mm). This ensures flexibility in use depending on the clinical scenario or patient needs.

  • How is the AutoCap RX supplied, and is it intended for single-use or reusable applications?

    The AutoCap RX is supplied as a reusable device, meaning it is designed for repeated use in clinical settings. Proper cleaning and maintenance per manufacturer guidelines are required to ensure functionality and longevity.

  • What regulatory pathways has the AutoCap RX followed, and which committees were involved in its review?

    The AutoCap RX has undergone FDA 510(k) clearance and MDR compliance, with its review conducted by the Gastroenterology and Urology advisory committees (GU). The device was deemed substantially equivalent to existing products under the traditional clearance pathway.