510(k) K211975 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
| Applicant | Caldera Medical, Inc., Westlake Village CA, US |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Jun 25, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211975
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.