510(k) K192811 ยท HIH Hysteroscope (And Accessories)
BenestaTM Tissue Removal Device
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, Oct 23, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192811
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.