510(k) K003201 ยท HAW Neurological Stereotaxic Instrument
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
| Applicant | Medtronic Surgical Navigation Technologies, Louisville CO, US |
| Decision | Substantially Equivalent, Dec 12, 2000 |
| Received | Oct 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003201
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2016 | Medtronic Navigation, Inc. BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization
The Adapter Kit is used during surgical procedures as an instrument guide holde Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.