# K992404: The Wand

- Pathway: 510(k) (Traditional)
- Applicant: Spintech, Inc.
- Decided: Jun 6, 2000 after 323 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
Longest line of descent: 2 generations back to K961648 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961648: The Wand, Spintech, Inc. (1996) Summary page 1.
- K962614: Shifa Sterile Disposable Syringes, International Regulatory Consultants (1996) Summary page 1.
- K983105: CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements), Model # CCS-100-01, Dentsply Midwest (1999) Summary page 1.

## Indications for use
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.

Source page: https://510kreport.com/device/K992404
Methodology: https://510kreport.com/methodology