Data / Medical devices / United States / FHC, Inc.
FHC, Inc.: FDA-registered device maker in Bowdoin, ME, United States, 15 510(k) clearances
FHC, Inc. is registered with the FDA (registration 3002250546) in Bowdoin, ME, United States. It lists 7 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 8, 2023. 9 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3002250546
- Address
- 1201 Main ST, Bowdoin, ME, United States, 04287
- Owner or operator
- FHC, Inc. (9037838)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 10, 2006
- Registered through
- 2027
- Brand names listed
- DP Stylet 5x 204mm, MICROTARGETING DRIVE SYSTEM, MICROTARGETING GUIDELINE 4000, NexDrive, NexFrame, Nexprobe, Passive Headrest, STarFix Designer Software and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Depth | GZL | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Manufacturer | accessdata.fda.gov |
| Surgical Planning Software For Neurological Stereotaxic Instruments | QRI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2023 | K231141 | STarFix Designer Software C0265 | QRI | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| May 14, 2020 | K200169 | VFS1 Bipolar Electrosurgical Generator | GEI | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| December 20, 2018 | K183123 | microTargeting Guideline 4000 5.0 System | GZL | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| July 26, 2012 | K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | HAW | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| February 12, 2010 | K092192 | WAYPOINT STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| September 18, 2009 | K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | HAW | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| July 25, 2007 | K071364 | MICROTARGETING GUIDELINE 4000 | GZL | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| October 4, 2004 | K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | HAW | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| March 24, 2004 | K033173 | MICRO TARGETING ELECTRODE | GZL | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| March 2, 2004 | K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | HAW | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| August 21, 2003 | K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | HBL | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| September 25, 2002 | K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | HAW | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| October 1, 2001 | K012366 | NAVIGUS II TRAJECTORY GUIDE | HAW | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| August 30, 2001 | K011775 | MICRO TARGETING DRIVE SYSTEM | HAW | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
| August 14, 2001 | K011992 | FHC MICROTARGETING DRIVE SYSTEM | HAW | Substantially Equivalent | FHC, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 4, 2024 | 95479 | Class I | Ongoing | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures. | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging | accessdata.fda.gov |
| June 17, 2020 | 85897 | Class II | Terminated | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Num | An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur. | accessdata.fda.gov |
| May 10, 2018 | 80148 | Class II | Terminated | microTargeting" Drive System, Product Number MT-DS | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. | accessdata.fda.gov |
| March 30, 2010 | 55287 | Not yet classified | Terminated | microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | accessdata.fda.gov |
| December 28, 2009 | 54278 | Not yet classified | Terminated | FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures. | The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location. | accessdata.fda.gov |
| October 20, 2008 | 50103 | Not yet classified | Terminated | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. | Mislabeled: May contain an electrode longer than labeled size | accessdata.fda.gov |
| October 8, 2008 | 50086 | Not yet classified | Terminated | FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating el | Measuring fixture is incorrectly graduated. | accessdata.fda.gov |
| October 31, 2005 | 33946 | Not yet classified | Terminated | FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD. | Power Assist microTargeting System may advance beyond intended target | accessdata.fda.gov |
| March 14, 2005 | 31718 | Not yet classified | Terminated | FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN) | Potential for non-sterile pin to contaminate sterile field | accessdata.fda.gov |
Compare with other makers
- All makers of Neurological Stereotaxic Instrument
- All makers of Electrode, Depth
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Stylet, Surgical, General & Plastic Surgery
- All makers of Instrument, Surgical, Non-Powered
Updated November 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.