# FHC, Inc.

- Location (FDA's records): Bowdoin, ME
- FDA decisions: 12 (2000–2023): 12 510(k) clearances
- Product codes: HAW (6), GZL (4), QRI (1), GEI (1)
- Predicates its devices cite: 23 (8 its own); citations of its devices by later devices: 18 (8 its own)
- Recalls linked to its devices: 29 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Microrecording Systems Consultants, LLC: 3 (https://510kreport.com/company/microrecording-systems-consultants)
- Radionics, Inc.: 3 (https://510kreport.com/company/radionics)
- Axon Instruments, Inc.: 2 (https://510kreport.com/company/axon-instruments)
- Valley Forge Scientific Corp.: 2 (https://510kreport.com/company/valley-forge-scientific)
- Elekta Instrument AB: 2 (https://510kreport.com/company/elekta-instrument)
- Alpha Omega, Ltd.: 1 (https://510kreport.com/company/alpha-omega)
- Preferred Instruments: 1 (https://510kreport.com/company/preferred-instruments)
- Howmedica Leibinger, Inc.: 1 (https://510kreport.com/company/howmedica-leibinger)

## Firms that cite its devices most
- Microprobes For Life Science, Inc. Dba Neuron: 2 (https://510kreport.com/company/microprobes-for-life-science-dba-neuron)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Elekta Instrument AB: 1 (https://510kreport.com/company/elekta-instrument)
- Inomed GmbH: 1 (https://510kreport.com/company/inomed)
- Alpine Biomed Aps: 1 (https://510kreport.com/company/alpine-biomed)
- Fred Haer Company, Inc.: 1 (https://510kreport.com/company/fred-haer)
- Neuralynx, Inc.: 1 (https://510kreport.com/company/neuralynx)
- We Sense, Ltd.: 1 (https://510kreport.com/company/we-sense)

## Its most-cited devices
- K003776: Microtargeting Drive System (2001), cited by 4
- K033173: Micro Targeting Electrode (2004), cited by 4
- K092192: Waypoint Stereotactic System (2010), cited by 3
- K071364: Microtargeting Guideline 4000 (2007), cited by 2
- K991522: Microtargeting Electrode (2000), cited by 2
- K183123: microTargeting Guideline 4000 5.0 System (2018), cited by 1

## Recent decisions
- K231141: STarFix Designer Software C0265 (Sep 8, 2023)
- K200169: VFS1 Bipolar Electrosurgical Generator (May 14, 2020)
- K183123: microTargeting Guideline 4000 5.0 System (Dec 20, 2018)
- K121950: Microtargeting XL Star Drive System (Jul 26, 2012)
- K092192: Waypoint Stereotactic System (Feb 12, 2010)
- K092562: Microtargeting Star Drive System, Components (Sep 18, 2009)
- K071364: Microtargeting Guideline 4000 (Jul 25, 2007)
- K033173: Micro Targeting Electrode (Mar 24, 2004)

Source page: https://510kreport.com/company/fhc