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Neuromate Frameless Gen II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132755

by Renishaw Mayfield SARL

Identifiers

510(k) Number
K132755 FDA 510(k)
FDA Product Code
HAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neuromate Frameless Gen II is a computer-controlled, electromechanical robotic arm designed for stereotactic neurosurgery. It functions as a precision guidance system for neurosurgical instruments, delivering stable, accurate, and repeatable mechanical alignment during operative procedures.

This device is intended for use in operating rooms by neurosurgeons and is supplied as a reusable, non-sterile system. It has received FDA 510(k) clearance under the Traditional pathway, with a clearance number of K132755. The device is manufactured by Renishaw Mayfield SARL, based in Chassieu, France.

Frequently asked questions

What is the Neuromate Frameless Gen II primarily used for in the operating room?

The Neuromate Frameless Gen II is designed as a precision guidance system for neurosurgical instruments during stereotactic neurosurgery. It provides stable, accurate, and repeatable mechanical alignment to assist neurosurgeons in performing procedures with enhanced spatial control and reliability.

Is the Neuromate Frameless Gen II intended for single-use or can it be reused?

The Neuromate Frameless Gen II is supplied as a reusable system, meaning it is not intended for single-use. However, it is provided in a non-sterile state and must be properly sterilized and maintained according to manufacturer guidelines before each use.

How is the Neuromate Frameless Gen II regulated in the United States?

The Neuromate Frameless Gen II has received FDA clearance under the Traditional 510(k) pathway, specifically classified as substantially equivalent to a predicate device. The clearance number is K132755, and it was reviewed by the Neurology (NE) Advisory Committee.

What type of environment is the Neuromate Frameless Gen II intended for, and how should it be stored?

The Neuromate Frameless Gen II is intended for use in operating rooms by neurosurgeons. While the device is reusable and non-sterile as supplied, storage conditions should follow manufacturer recommendations to ensure proper functionality and longevity, typically involving clean, controlled environments away from direct contamination.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: neuro | mate Frameless Gen II stereotactic robot - renishaw.com, neuro | mate Frameless Gen II stereotactic robot - renishaw.com, NEUROMATE FRAMELESS GEN II (K132755) — FDA 510(k) | Innolitics, Renishaw neuromate frameless Gen II cleared by the FDA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Renishaw Mayfield SARL

Sources (1)

  • FDA 510(k) K132755 24 fields · synced Sep 19, 2026