Identifiers
- 510(k) Number
- K190163 FDA 510(k)
- FDA Product Code
- PDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1820 FDA 510(k)
- Regulation Number
- 874.1820 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ALARA Neuro Access Kit is a neurosurgical nerve locator device used for nerve identification during surgical procedures. It is designed to assist surgeons in locating nerves with precision during ear, nose, and throat surgeries.
The device is supplied as a single-use kit and is regulated under FDA 510K clearance with device class 2. It is manufactured by SurGenTec, LLC and is intended for use in sterile surgical environments. The device is not MRI compatible and should be stored according to manufacturer instructions.
Frequently asked questions
What is the ALARA Neuro Access Kit used for?
The ALARA Neuro Access Kit is a neurosurgical nerve locator device designed to assist surgeons in locating nerves with precision during ear, nose, and throat surgeries. It helps improve surgical accuracy by providing nerve identification capabilities.
Is the ALARA Neuro Access Kit single-use or reusable?
The ALARA Neuro Access Kit is supplied as a single-use kit, meaning it is designed for one surgical procedure only and should not be reused. This ensures sterility and optimal performance for each patient.
What regulatory approvals does the ALARA Neuro Access Kit have?
The ALARA Neuro Access Kit is regulated under FDA 510K clearance with device class 2. It received traditional clearance with a decision code of SESE (Substantially Equivalent) on July 16, 2019, with K number K190163.
Is the ALARA Neuro Access Kit MRI compatible?
No, the ALARA Neuro Access Kit is not MRI compatible. It should be stored according to the manufacturer's instructions and should not be used in MRI environments to ensure patient safety and device functionality.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190163 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgentec, Llc
Sources (1)
- FDA 510(k) K190163 24 fields · synced Sep 21, 2026