510(k) K191416 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, Feb 7, 2020 |
| Received | May 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191416
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.