# K091818: Laurimed Spinal Injection System

- Pathway: 510(k) (Special)
- Applicant: Laurimed, LLC
- Decided: Sep 23, 2009 after 97 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- 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
Longest line of descent: 5 generations back to K801941 (1980). 18 ancestors in all.
No later device cites it as a predicate yet.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083909: Spinal Injection System, Laurimed, LLC (2009) Summary page 1.

## Indications for use
The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Source page: https://510kreport.com/device/K091818
Methodology: https://510kreport.com/methodology