# K180206: neuromate Gen III

- Pathway: 510(k) (Traditional)
- Applicant: Renishaw Mayfield Sarl
- Decided: Apr 24, 2018 after 90 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K811452 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132755: Neuromate Frameless Gen II, Renishaw Mayfield Sarl (2014) Summary page 4.

## Indications for use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).

Source page: https://510kreport.com/device/K180206
Methodology: https://510kreport.com/methodology