Company ยท US
FHC, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
29recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2023 | K231141 | STarFix Designer Software C0265 FHC, Inc. | QRI |
| May 14, 2020 | K200169 | VFS1 Bipolar Electrosurgical Generator FHC, Inc. | GEI |
| Dec 20, 2018 | K183123 | microTargeting Guideline 4000 5.0 System FHC, Inc. | GZL |
| Jul 26, 2012 | K121950 | MICROTARGETING XL STAR DRIVE SYSTEM FHC, Inc. | HAW |
| Feb 12, 2010 | K092192 | WAYPOINT STEREOTACTIC SYSTEM FHC, Inc. | HAW |
| Sep 18, 2009 | K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS FHC, Inc. | HAW |
| Jul 25, 2007 | K071364 | MICROTARGETING GUIDELINE 4000 FHC, Inc. | GZL |
| Mar 24, 2004 | K033173 | MICRO TARGETING ELECTRODE FHC, Inc. | GZL |
| Aug 30, 2001 | K011775 | MICRO TARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Aug 14, 2001 | K011992 | FHC MICROTARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Feb 23, 2001 | K003776 | MICROTARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Aug 4, 2000 | K991522 | MICROTARGETING ELECTRODE FHC, Inc. | GZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2024 | FHC, Inc. 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 procedure Open, Classified |
HAW | K011775 |
| Jun 17, 2020 | FHC, Inc. 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 instr Terminated |
GZL | K183123 |
| May 10, 2018 | FHC, Inc. microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), Terminated |
HAW | K011992 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter
for microTargeting" Drive, Product Number 66-CN-DB Terminated |
HAW | K011992 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number 70-ZD-ME Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number 70-ZD-MA Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number ST-DS-ME Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number ST-DS-MA Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD-01 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS-01 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS Terminated |
HAW | K011775 |
| Nov 3, 2010 | FHC, Inc. Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives
Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Driv Terminated |
HAW | K003776 K092562 |
| Nov 3, 2010 | FHC, Inc. microTargeting Drive DBS Lead Holder 66-CN-DB
Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commerciall Terminated |
HAW | K003776 |
| Nov 3, 2010 | FHC, Inc. STar Drive System,
Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME
Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be Terminated |
HAW | K092562 |
| Nov 3, 2010 | FHC, Inc. 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 Terminated |
HAW | K003776 |
| Mar 16, 2010 | FHC, Inc. FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software,
Catalog # MT-GL4K.
Intended to assist in functional neurological procedures. Terminated |
GZL | K071364 |
| Dec 22, 2008 | FHC, Inc. 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 recordi Terminated |
HAW | K011992 |
| Dec 18, 2008 | FHC, Inc. FC400SP microTargeting StimPilot Single Procedure Kit
Distributed by Medtronic Inc., Minneapolis, MN
Ref: FHC4000SP
Intended for use in intra-operative recording of single unit neuronal activity or Terminated |
GZL | K991522 |
| Dec 18, 2008 | FHC, Inc. FC4000 MicroTargeting Electrode Kit 5x
For use with Nexframe and Nexdrive
Distributed by Medtronic Inc., Minneapolis, MN
REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each)
Terminated |
GZL | K991522 |
| Dec 18, 2008 | FHC, Inc. 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. Terminated |
GZL | K991522 |
| Nov 23, 2005 | FHC, Inc. Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66 Terminated |
HAW | K011992 |
| Nov 23, 2005 | FHC, Inc. 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. Terminated |
HAW | K011992 |
| Jun 16, 2005 | FHC, Inc. 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) Terminated |
HAW | K003776 K011775 +1 |