510(k) K190672 ยท HAW Neurological Stereotaxic Instrument
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jul 31, 2019 |
| Received | Mar 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190672
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Open, Classified |
HAW | None listed |
| Nov 11, 2021 | Medtronic Navigation, Inc. Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software.
Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585 Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.