510(k) K211858 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
TULSA-PRO System
| Applicant | Profound Medical, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Sep 6, 2022 |
| Received | Jun 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211858
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.