510(k) K172048 ยท HIG Insufflator, Hysteroscopic
FluidSmart
| Applicant | Thermedx, LLC, Solon OH, US |
| Decision | Substantially Equivalent, Sep 5, 2017 |
| Received | Jul 6, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Stryker Corporation Thermedx FluidSmart Urology Tube Set REF LL0006
UDI-DI code: 00860936000365
The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigat Open, Classified |
HIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.