Identity
- Trade Name
- microTargeting™ Insertion Tube FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, single-use FDA UDI
- Device Name
- microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar and MT Drive FDA UDI
- Model / Reference
- FC1019-00895 FDA UDIFC1019-00762 FDA UDI
- Description
- microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar and MT Drive FDA UDI
Identifiers
- Catalog Number
- FC1019 FDA UDI
- Primary DI / UDI-DI
- 10873263008956 FDA UDI10873263007621 FDA UDI
- 510(k) Number
- K011775 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
Yes
FDA UDIFDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1.6 Millimeter FDA UDIOuter Diameter — 1.83 Millimeter FDA UDILength — 243.5 Millimeter FDA UDI
Category: Intracerebral cannula, nonimplantable, single-use
microTargeting™ 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
K011775 also covers:
- 33 cm Lead Insertion Tube Set — FHC, INC.
- Microtargeting ™ STar Drive Adapter — FHC, INC.
- STar™ Drive Insertion Tube Extractor — FHC, INC.
- microTargeting Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
- microTargeting™ Electrode and Insertion Tube — FHC, INC.
- microTargeting™ Frame Adapter — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — 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 (2)
- FDA UDI b94c900a-33dc-4e69-808f-c4813f481c26 38 fields · synced Jun 8, 2026
- FDA UDI bbd32e4b-b15b-477a-b6bc-16d07cbc7d1d 38 fields · synced May 26, 2026