510(k) K221874 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Altis Single Incision Sling System
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 15, 2023 |
| Received | Jun 28, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221874
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.