# K212982: Medispine - Spinal Needle, Glospine - Spinal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Global Medikit Limited
- Decided: Jul 29, 2022 after 315 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: 7 generations back to K932249 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles, Zhejiang Kindly Medical Devices Co., Ltd. (2018) Summary page 4.

## Indications for use
Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.

Source page: https://510kreport.com/device/K212982
Methodology: https://510kreport.com/methodology