# K081404: Spinal Integration Spinal-Eze Intraoperative Epidural Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Integration, LLC
- Decided: Oct 21, 2008 after 155 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 K813186 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991543: Intraop Catheter, I-Flow Corp. (1999) Summary page 1.
- K840202: Epidural Catheter, Aries Medical, Inc. (1984) Summary page 1.

## Indications for use
The Spinal-EZE TM Intraoperative Epidural Catheter Kit is intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection location is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE TM Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.

Source page: https://510kreport.com/device/K081404
Methodology: https://510kreport.com/methodology