# K904380: Spinal Cord Access Epidural Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Custom Medical Concepts, Inc.
- Decided: Apr 8, 1993 after 925 days
- Product code: MIA (Needle, Spinal, Short Term)
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051860: Flexible Introducer Cannula, Model 135-1837 (2005), 1 descendant of its own
- K200624: Percutaneous Introducer (2020), 0 descendants of its own
- K043467: Flexible Spinal Needle (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K904380
Methodology: https://510kreport.com/methodology