510(k) K011775 ยท HAW Neurological Stereotaxic Instrument
MICRO TARGETING DRIVE SYSTEM
| Applicant | FHC, Inc., Bowdoinham ME, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Jun 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2024 | FHC, Inc. microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedure Open, Classified |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS-01 Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD-01 Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 Terminated |
HAW | None listed |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 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.