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Epiducer Lead Delivery System

by St Jude Medical

510(k) K110609

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK110609 Date24 Jun 2011ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LHG
Device class
Class II
Regulation
21 CFR Part 882.5880
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Epiducer Lead Delivery System is an electrode, spinal epidural device that functions as an accessory for neurostimulation lead placement. It is designed to introduce Lamitrode S-Series paddle leads and St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.

This device allows for the introduction of S-Series perc-paddle leads and multiple lead arrays through a single percutaneous entry point. The system has received FDA 510(k) clearance and CE Mark approval for use in neurostimulation therapy.

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Questions

AI-generated answers, 24 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 primary function of the Epiducer Lead Delivery System?

    This device serves as an accessory for neurostimulation lead placement. It is specifically designed to facilitate the introduction of Lamitrode S-Series paddle leads and St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.

  • Can this system accommodate multiple leads?

    Yes, the system is designed to allow for the introduction of S-Series perc-paddle leads and multiple lead arrays through a single percutaneous entry point, which helps streamline the placement process.

  • What are the regulatory authorizations for this device?

    The Epiducer Lead Delivery System has received FDA 510(k) clearance and CE Mark approval for use in neurostimulation therapy, confirming it has been reviewed and authorized for clinical use within those regulatory frameworks.