510(k) K092562 ยท HAW Neurological Stereotaxic Instrument
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
| Applicant | FHC, Inc., Bowdoin ME, US |
| Decision | Substantially Equivalent, Sep 18, 2009 |
| Received | Aug 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number ST-DS-MA Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number ST-DS-ME Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number 70-ZD-MA Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number 70-ZD-ME Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 Terminated |
HAW | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.