510(k) K211269 ยท ONO Neurosurgical Laser With Mr Thermography
Visualase MRI-Guided Laser Ablation System (SW 3.4)
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Apr 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2022 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE
FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. Open, Classified |
ONO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.