510(k) K162388 ยท FTM Mesh, Surgical
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
| Applicant | Curaseal, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 3, 2017 |
| Received | Aug 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162388
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.