# K181706: neuromate Gen III

- Pathway: 510(k) (Special)
- Applicant: Renishaw Mayfield Sarl
- Decided: Jul 26, 2018 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 following stereotactic frames: 1 - the Leksell Type G comprising of head frame and CT Localizer, 2 - the CRW HRAIM with the BRWLF localizer, 3 - the CRW UCHRA with the Luminant and BRWLF localizers

Source page: https://510kreport.com/device/K181706
Methodology: https://510kreport.com/methodology