510(k) Report

FDA applicant

FHC, Inc.

Bowdoin, ME12 decisions2000–202329 recalls

FDA records 12 decisions for FHC, Inc. (Bowdoin, ME) from 2000 to 2023: 12 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and GZL (Electrode, Depth). Its devices cite 23 predicates, 8 of them its own earlier devices. 29 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided FHC, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12009: 12010: 12012: 12018: 12020: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2008: 42009: 12010: 42018: 152020: 12024: 1, 1 Class I
2007high 15 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — FHC, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like FHC, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument6decisions
  • GZLElectrode, Depth4decisions
  • QRISurgical Planning Software For Neurological Stereotaxic Instruments1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 23 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003776Microtargeting Drive SystemFHC, Inc. · 20014cite it
  • K033173Micro Targeting ElectrodeFHC, Inc. · 20044cite it
  • K092192Waypoint Stereotactic SystemFHC, Inc. · 20103cite it
  • K071364Microtargeting Guideline 4000FHC, Inc. · 20072cite it
  • K991522Microtargeting ElectrodeFHC, Inc. · 20002cite it
  • K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 20181cites it

What has FDA decided for it lately?

  • K231141STarFix Designer Software C0265FHC, Inc. · 2023
  • K200169VFS1 Bipolar Electrosurgical GeneratorFHC, Inc. · 2020
  • K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 20181 recall
  • K121950Microtargeting XL Star Drive SystemFHC, Inc. · 2012
  • K092192Waypoint Stereotactic SystemFHC, Inc. · 2010
  • K092562Microtargeting Star Drive System, ComponentsFHC, Inc. · 20099 recalls
  • K071364Microtargeting Guideline 4000FHC, Inc. · 20071 recall
  • K033173Micro Targeting ElectrodeFHC, Inc. · 2004

All 12 as FHC, Inc. →

What has been recalled?

29 recalls linked to its devices; the latest:

  • K011775microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to…Oct 4, 2024Class I
  • K183123FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and…Jun 17, 2020Class II
  • K011775microTargeting" Drive System, Product Number MT-DS-01May 10, 2018Class II
  • K092562microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number…May 10, 2018Class II
  • K011775microTargeting" Drive System Distributed by Medtronic, Product Number FC1006May 10, 2018Class II
  • K092562microTargeting" STar" Drive System (Manual), Product Number ST-DS-MAMay 10, 2018Class II