# K994097: Medamicus Epidural Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Mar 1, 2000 after 89 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: 2 generations back to K932323 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set, Medamicus, Inc. (1999) Summary page 1.
- K930242: Introde Int-8, Neuromed, Inc. (1994) Summary page 1.

## Most influential descendants
- K013120: Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 (2002), 0 descendants of its own

## Indications for use
For percutaneous introduction, manipulation, and removal of epidural stimulation leads.

Source page: https://510kreport.com/device/K994097
Methodology: https://510kreport.com/methodology