# K083909: Spinal Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Laurimed, LLC
- Decided: Mar 18, 2009 after 78 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: 4 generations back to K801941 (1980). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080140: Laurimed Spinal Injection System, Laurimed, LLC (2008) Summary page 1.

## Most influential descendants
- K091818: Laurimed Spinal Injection System (2009), 0 descendants of its own

## Indications for use
Spinal epidural injections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.

Source page: https://510kreport.com/device/K083909
Methodology: https://510kreport.com/methodology