neuro inspire
by Rensihaw Plc
510(k) K163666
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163666 | Date15 Sep 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Neuro Inspire is a neurosurgical planning software designed for stereotactic procedure planning. It integrates with robotic systems, such as the neuromate® stereotactic robot, to assist in precise surgical navigation and trajectory planning. The software provides tools for pre-operative planning, intra-operative verification, and customizable modules to address specific clinical needs. Its primary function is to enhance surgical accuracy and efficiency in neurosurgical interventions.
Supplied as a digital platform, Neuro Inspire is intended for use in operating rooms and neurosurgical planning suites. It is not classified as a sterile or single-use device but is regulated under FDA 510(k) clearance (K163666) as a Class 2 Neurology device with product code HAW. The software operates within MRI-safe environments and requires compatible hardware for integration. No specific sterility or reuse guidelines apply, as it is a reusable digital tool. Authorisation is granted through the Traditional 510(k) pathway.
Questions
AI-generated answers, 1 Oct 2026
What is the Neuro Inspire software designed for?
The Neuro Inspire is a neurosurgical planning software specifically designed for stereotactic procedure planning. It enhances surgical accuracy and efficiency by providing tools for pre-operative planning and intra-operative verification. The software integrates with robotic systems, such as the neuromate® stereotactic robot, to assist in precise navigation and trajectory planning during neurosurgical interventions.
How is the Neuro Inspire supplied and where can it be used?
Neuro Inspire is supplied as a digital platform and is intended for use in operating rooms and neurosurgical planning suites. Since it is a reusable digital tool, no physical supply or sterility considerations apply. It requires compatible hardware for integration and operates within MRI-safe environments.
Is the Neuro Inspire a sterile or single-use device?
No, Neuro Inspire is not classified as a sterile or single-use device. It is a reusable digital platform, meaning it does not require sterilization or disposal after use. The software’s regulatory status reflects this, as it is governed under FDA 510(k) clearance for reusable Class 2 Neurology devices.
What regulatory pathway does Neuro Inspire follow?
Neuro Inspire is regulated through the Traditional 510(k) pathway and holds FDA 510(k) clearance (K163666) as a Class 2 Neurology device with product code HAW. This pathway confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for neurosurgical planning software.
Does Neuro Inspire support customizable modules for specific clinical needs?
Yes, Neuro Inspire includes customizable modules tailored to address specific clinical requirements. These modules allow clinicians to adapt the software to their unique procedural workflows, further enhancing its utility in stereotactic neurosurgery. The software’s flexibility ensures it can be optimized for various surgical scenarios.