# K201308: Axonpen, Axonmonitor, Axonbox, Tablet

- Pathway: 510(k) (Traditional)
- Applicant: Clearmind Biomedical
- Decided: Nov 27, 2020 after 196 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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 K853143 (1985). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171332: Artemis Neuro Evacuation Device, Penumbra, Inc. (2017) Summary page 4.
- K190719: Artemis Eye System, Penumbra, Inc. (2019) Summary page 4.

## Most influential descendants
- K230125: Neuroblade System (2023), 0 descendants of its own

## Indications for use
The Axonpen System is indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

Source page: https://510kreport.com/device/K201308
Methodology: https://510kreport.com/methodology