Identity
- Trade Name
- microTargeting™ STar™ Insertion Tube FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, single-use FDA UDI
- Device Name
- microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive. Each Kit Contains: IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain) IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID FDA UDI
- Model / Reference
- FC9001-00766 FDA UDI
- Description
- microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive. Each Kit Contains: IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain) IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID FDA UDI
Identifiers
- Catalog Number
- FC9001 FDA UDI
- Primary DI / UDI-DI
- 10873263007669 FDA UDI
- 510(k) Number
- K092562 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Intracerebral cannula, nonimplantable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Intracerebral cannula, nonimplantable, single-use
microTargeting™ STar™ Insertion Tube by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral cannula, nonimplantable, single-use.
- Smartflow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class II
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- Cannula Needle Set — KATALYST SURGICAL, LLC · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
Cleared under the same submission
K092562 also covers:
- Cable Management System — FHC, INC.
- Lower Lead Depth Stop — FHC, INC.
- STar™ Drive Accesories Kit — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI ad6cab9b-c0ef-437c-9749-7ef01fc2463c 37 fields · synced May 30, 2026