510(k) K003776 ยท HAW Neurological Stereotaxic Instrument
MICROTARGETING DRIVE SYSTEM
| Applicant | FHC, Inc., Bowdoinham ME, US |
| Decision | Substantially Equivalent, Feb 23, 2001 |
| Received | Dec 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003776
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | 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 |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.