# K112214: Octrodex (TM), Quattrodex (TM), Introdex (TM), Epidural Needle, Stylets

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical Neuromodulation
- Decided: Nov 17, 2011 after 107 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- 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
St. iude Medical Neuromodulation Division percutaneous trial leads and compatible accessories are indicated for spinal cord stimulation in the management 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 multidisciplinary approach. OctrodeX" and QuattrodeX" trial leads and their accessories are intended to be used during a spinal cord stimulation trial period for a maximum of 30 days.

Source page: https://510kreport.com/device/K112214
Methodology: https://510kreport.com/methodology