Identity
- Trade Name
- Lower Lead Depth Stop FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Lower Lead Depth Stop, 1x with hex wrench FDA UDI
- Model / Reference
- FC8014-00819 FDA UDI
- Description
- Lower Lead Depth Stop, 1x with hex wrench FDA UDI
Identifiers
- Catalog Number
- FC8014 FDA UDI
- Primary DI / UDI-DI
- 00873263008195 FDA UDI
- 510(k) Number
- K092562 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lower Lead Depth Stop by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 f993371e-dc71-49f1-9bfc-38f0841c1aa0 37 fields · synced May 30, 2026