# K955291: Dualscreen

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: May 17, 1996 after 183 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 3627 Screener: named in the summary without a submission number
- (no number) Model 3210 Transmitter: named in the summary without a submission number

## Indications for use
The Medtronic Model 3628 Screener is indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs, as is the Model 3627 Screener and the Model 3210 Transmitter.

Source page: https://510kreport.com/device/K955291
Methodology: https://510kreport.com/methodology