510(k) K011992 ยท HAW Neurological Stereotaxic Instrument
FHC MICROTARGETING DRIVE SYSTEM
| Applicant | FHC, Inc., Bowdoinham ME, US |
| Decision | Substantially Equivalent, Aug 14, 2001 |
| Received | Jun 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter
for microTargeting" Drive, Product Number 66-CN-DB Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), Terminated |
HAW | None listed |
| Dec 22, 2008 | FHC, Inc. FHC microTargeting Platform DBS Measuring Fixture,
a component of the micro-targeting Drive System (Catalog Number 66-FA-SF).
The device is a stereotactic instrument used for the placement of recordi Terminated |
HAW | None listed |
| Nov 23, 2005 | FHC, Inc. FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD. Terminated |
HAW | None listed |
| Nov 23, 2005 | FHC, Inc. Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66 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.