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Micro Targeting Electrode
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K033173
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Electrode FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- microTargeting Electrode, differential, platinum/iridium, DZAP(L), epoxylite insulated, nonsterile FDA UDI
- Model / Reference
- MTDPLN(PA)(DB2)-00329 FDA UDI
- Description
- microTargeting Electrode, differential, platinum/iridium, DZAP(L), epoxylite insulated, nonsterile FDA UDI
Identifiers
- Catalog Number
- MTDPLN(PA)(DB2) FDA UDI
- Primary DI / UDI-DI
- 10873263003296 FDA UDI
- 510(k) Number
- FDA Product Code
- GZL FDA 510(k)FDA UDI
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1330 FDA 510(k)
- Regulation Number
- 882.1330 FDA 510(k)FDA UDI
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Dimensions & Sizes
- Size
- Length — 234.2 Millimeter FDA UDILength — 249.2 Millimeter FDA UDIOuter Diameter — 0.56 Millimeter FDA UDILength — 10 Millimeter FDA UDI
Micro Targeting Electrode by Fhc, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033173 | Class II | Active |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (2)
- FDA 510(k) K033173 24 fields · synced Jun 18, 2026
- FDA UDI 14107641-8c7e-4d79-b18e-ac843199d39a 38 fields · synced May 27, 2026