510(k) K253642 ยท OQY Intrauterine Tamponade Balloon
Jada System (Jada-2002)
| Applicant | Organon, LLC, Jersey City NJ, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253642
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.