# K150789: Spinaut-E, Spinaut-I

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom Co., Ltd.
- Decided: Mar 1, 2016 after 342 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- 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 K954584 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980734: Myelotec Video Guided Catheter, Myelotec, Inc. (1998) Summary page 4.
- K032390: Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System, Ebi, L.P. (2003) Summary page 4.

## Most influential descendants
- K241410: EDEN ControlCath (2025), 0 descendants of its own

## Indications for use
SPINAUT-E is used for delivery of drugs that have been indicated for the epidural space. SPINAUT-I is intended for the percutaneous introduction and placement of an epidural catheter.

Source page: https://510kreport.com/device/K150789
Methodology: https://510kreport.com/methodology