510(k) K210087 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Athena Surgical RMUS System
| Applicant | Athena Surgical, LLC, Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 12, 2021 |
| Received | Jan 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210087
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.