510(k) K972398 ยท HAW Neurological Stereotaxic Instrument
STEALTHSTATION PASSIVE INSTRUMENT OPTION
| Applicant | Surgical Navigation Technologies, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Sep 16, 1997 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2015 | Medtronic Navigation, Inc. Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.