FDA Registration
Active
🇺🇸 United States
FHC, INC.
Reg #: 3002250546
·
FEI: 3002250546
·
Expires 2026
Products
7
Proprietary Names
26
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- FHC, INC.
- Registration Number
- 3002250546
- FEI Number
- 3002250546
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1201 MAIN ST
- City
- Bowdoin
- State
- ME
- ZIP
- 04287
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040334
Owner / Operator
- Firm Name
- FHC, Inc.
- Operator Number
- 9037838
- Address
- 1201 Main St., --
- City
- Bowdoin
- State
- ME
- Postal Code
- 04287
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2020-10-15 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2007-11-06 |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2020-10-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-07-10 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2015-03-06 |
| Surgical Planning Software For Neurological Stereotaxic Instruments | QRI | Class 2 | Neurology | No | 2023-09-11 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2025-02-12 |
Proprietary Names
Nexprobe
microTargeting Electrode 1(electrode type)2(material with insulation)3(impedance)4(sterility)(x)(y)variations
Passive Headrest
microTargeting Drive System Acc.
WayPoint Stereotactic System
microTargeting XL STar Drive System
microTargeting(TM) Guideline 4000(TM) 5 System
VFS1 Bipolar Electrosurgical Generator
NexDrive
Visualase Anchor Bolt Removal Tool
DP Stylet 5x 204mm
Visualase Anchor Bolt Tools
Visualase Driver Guide for CRW
Visualase Neuro Accessories
Visualase Driver Guide for Leksell
Visualase Sterilization & Storage Tray
Visualase Driver Guide for ROSA ONE
Visualase Driver Guide for Autoguide
Visualase Anchor Bolt Driver
STarFix Designer Software
microTargeting STar Drive System
NexFrame
MICROTARGETING DRIVE SYSTEM
MICROTARGETING GUIDELINE 4000
Unibody Bone Fiducials
Visualase Stylet and accessories
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198