510(k) K262570 ยท PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
TZ Medical Birthing Balloon Kit
| Applicant | TZ Medical, Tualatin OR, US |
| Decision | Substantially Equivalent, Oct 29, 2026 |
| Received | Jul 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262570
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.