510(k) K183134 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
ArcTV Transvaginal Sling System
| Applicant | Urocure, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 7, 2019 |
| Received | Nov 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183134
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.