510(k) K212150 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Exablate Prostate System
| Applicant | Insightec, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Nov 23, 2021 |
| Received | Jul 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212150
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.