510(k) K172614 ยท PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, May 4, 2018 |
| Received | Aug 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172614
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.