FHC, Inc.
FDA Regulatory Profile
FHC, Inc. appears in FDA public data with 17 recalls — including 1 Class I (most serious) —, 12 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0312-2025, Class I) was initiated on October 4, 2024. Its most recent 510(k) clearance was granted on September 8, 2023.
Summary
- Total Recalls
- 17 (1 Class I)
- 510(k) Clearances
- 12
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0312-2025 | Class I | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guid | October 4, 2024 |
| Z-2540-2020 | Class II | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate e | June 17, 2020 |
| Z-2357-2018 | Class II | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 | May 10, 2018 |
| Z-2358-2018 | Class II | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 | May 10, 2018 |
| Z-2355-2018 | Class II | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 | May 10, 2018 |
| Z-2348-2018 | Class II | microTargeting" Drive System, Product Number 66-ZD-MD-01 | May 10, 2018 |
| Z-2356-2018 | Class II | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 | May 10, 2018 |
| Z-2354-2018 | Class II | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB | May 10, 2018 |
| Z-2347-2018 | Class II | microTargeting" Drive System, Product Number 66-ZD-MD | May 10, 2018 |
| Z-2349-2018 | Class II | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA | May 10, 2018 |
| Z-2352-2018 | Class II | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME | May 10, 2018 |
| Z-2353-2018 | Class II | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB | May 10, 2018 |
| Z-2350-2018 | Class II | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME | May 10, 2018 |
| Z-2345-2018 | Class II | microTargeting" Drive System, Product Number MT-DS | May 10, 2018 |
| Z-2351-2018 | Class II | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA | May 10, 2018 |
| Z-2359-2018 | Class II | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), | May 10, 2018 |
| Z-2346-2018 | Class II | microTargeting" Drive System, Product Number MT-DS-01 | May 10, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231141 | STarFix Designer Software C0265 | September 8, 2023 |
| K200169 | VFS1 Bipolar Electrosurgical Generator | May 14, 2020 |
| K183123 | microTargeting Guideline 4000 5.0 System | December 20, 2018 |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | July 26, 2012 |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | February 12, 2010 |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | September 18, 2009 |
| K071364 | MICROTARGETING GUIDELINE 4000 | July 25, 2007 |
| K033173 | MICRO TARGETING ELECTRODE | March 24, 2004 |
| K011775 | MICRO TARGETING DRIVE SYSTEM | August 30, 2001 |
| K011992 | FHC MICROTARGETING DRIVE SYSTEM | August 14, 2001 |
| K003776 | MICROTARGETING DRIVE SYSTEM | February 23, 2001 |
| K991522 | MICROTARGETING ELECTRODE | August 4, 2000 |