# K021084: Light Saber Spinal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Minrad, Inc.
- Decided: Jul 3, 2002 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spinal Needle, Ballard Medical Products: named in the summary without a submission number
- (no number) Light Saber Aspiration Needle, MINRAD, Inc.: named in the summary without a submission number

## Indications for use
A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.’s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.

Source page: https://510kreport.com/device/K021084
Methodology: https://510kreport.com/methodology