510(k) K210138 ยท QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
iTind System
| Applicant | Medi-Tate , Ltd., Hadera, IL |
| Decision | Substantially Equivalent, Jun 25, 2021 |
| Received | Jan 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210138
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.