# K110609: Epiducer Lead Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jun 24, 2011 after 113 days
- Product code: LHG (Electrode, Spinal Epidural)
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Epiducer system is an accessory to the leads component of St. Jude Medical Neuromodulation Division neurostimulation systems, which are indicated for spinal cord stimulation (SOS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multi-disciplinary approach. The EpiducerTM lead delivery system is intended to introduce Lamitrode S-Series paddle leads and/or St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below theil1 vertebra.

Source page: https://510kreport.com/device/K110609
Methodology: https://510kreport.com/methodology