# K210251: ClearPath Disposable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Clearmind Biomedical
- Decided: Apr 2, 2021 after 63 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: 1 generation back to K142315 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142315: MINOP Disposable Introducer 26F, Aesculap, Inc. (2014) Summary page 4.

## Indications for use
The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

Source page: https://510kreport.com/device/K210251
Methodology: https://510kreport.com/methodology