# K043467: Flexible Spinal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Mar 31, 2005 after 106 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: 1 generation back to K904380 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022029: Quincke Spinal Needle, Epimed International, Inc. (2002) Summary page 2.
- K904380: Spinal Cord Access Epidural Introducer System, Custom Medical Concepts, Inc. (1993) Summary page 2.

## Indications for use
The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

Source page: https://510kreport.com/device/K043467
Methodology: https://510kreport.com/methodology