# K013120: Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jan 24, 2002 after 128 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
Longest line of descent: 3 generations back to K932323 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994097: Medamicus Epidural Introducer, Medamicus, Inc. (2000) Summary page 3.

## Indications for use
The Percutaneous Introducer Set is indicated for percutaneous introduction, manipulation, and removal of stimulation leads.

Source page: https://510kreport.com/device/K013120
Methodology: https://510kreport.com/methodology