# K150378: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook

- Pathway: 510(k) (Traditional)
- Applicant: Nico Corporation
- Decided: Jun 12, 2015 after 119 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- 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 K002931 (2000). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120691: Brain Port, Nico Corporation (2012) Summary page 4.

## Most influential descendants
- K172433: NICO BrainPath (2017), 1 descendant of its own
- K202072: MindsEye Expandable Port (2020), 0 descendants of its own

## Indications for use
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary Brain Tumors - Vascular Abnormalities/Malformations - Intraventricular Tumors/Cysts

Source page: https://510kreport.com/device/K150378
Methodology: https://510kreport.com/methodology