# K953742: Bifurcated Y-Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 19, 1996 after 469 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. The FDA summary names its predicate without a number.
- (no number) Model 7495 extension: named in the summary without a submission number
- (no number) Model 3470 receiver extensions: named in the summary without a submission number
- (no number) Model 3983: named in the summary without a submission number
- (no number) Model 3982: named in the summary without a submission number
- (no number) Model 3991: named in the summary without a submission number
- (no number) Model 3825 screening cable: named in the summary without a submission number

## Indications for use
Spinal Cord Stimulation to treat chronic intractable pain.

Source page: https://510kreport.com/device/K953742
Methodology: https://510kreport.com/methodology