# K230125: Neuroblade System

- Pathway: 510(k) (Traditional)
- Applicant: Clearmind Biomedical
- Decided: Oct 13, 2023 after 269 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: 5 generations back to K853143 (1985). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201308: Axonpen, Axonmonitor, Axonbox, Tablet, Clearmind Biomedical (2020) Summary page 5.
- K203745: AURORA Evacuator +Coag, Rebound Therapeutics (2021) Summary page 6.

## Indications for use
The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and/or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.

Source page: https://510kreport.com/device/K230125
Methodology: https://510kreport.com/methodology