510(k) K260114 · ITX Transducer, Ultrasonic, Diagnostic
Align® Cover and Pad Guidance Tool
| Applicant | CIVCO Medical Instruments Co., Inc., Coralville IA, US |
| Decision | Substantially Equivalent, Sep 24, 2026 |
| Received | Jan 14, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260114
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.