FHC Microtargeting Drive System
FDA 510(k)Class II (US FDA 510(k))
by Fhc, Inc.
Identifiers
- 510(k) Number
- K011992 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 FHC Microtargeting Drive System is a device used in neurology for microtargeting applications. It is designed to support precise neurological procedures through its drive mechanism.
The system is supplied as a reusable device and has received FDA 510(k) clearance under K011992. It is manufactured by FHC, Inc. and is intended for use in clinical settings requiring microtargeting functionality.
Frequently asked questions
What is the FHC Microtargeting Drive System used for?
The FHC Microtargeting Drive System is used in neurology for microtargeting applications, supporting precise neurological procedures through its drive mechanism to enable accurate targeting during clinical interventions.
Is the FHC Microtargeting Drive System reusable or single-use?
The FHC Microtargeting Drive System is supplied as a reusable device, meaning it can be cleaned, sterilized, and used multiple times in clinical settings following appropriate reprocessing protocols.
What regulatory clearance does the FHC Microtargeting Drive System have?
The FHC Microtargeting Drive System has received FDA 510(k) clearance under submission number K011992, indicating it was found substantially equivalent to a legally marketed predicate device.
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 | K011992 | Class II | Active |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA 510(k) K011992 24 fields · synced Sep 23, 2026