Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307)
Description
Visualase V2 MRI-guided Laser Ablation System (9736422) by Medtronic Navigation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250307
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022 |
Trace the full predicate network for K250307
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.