510(k) K012366 ยท HAW Neurological Stereotaxic Instrument
NAVIGUS II TRAJECTORY GUIDE
| Applicant | Image-Guided Neurologics, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 1, 2001 |
| Received | Jul 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2008 | Medtronic Image Guided Neurologics, Inc. Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041,
DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST,
DB-1043, DB-1043-BL, DB-1043-ST, DB-2 Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.