510(k) K150091 · FTL Mesh, Surgical, Polymeric
Versatex Monofilament Mesh
| Applicant | Sofradim Production, Trévoux, FR |
| Decision | Substantially Equivalent, May 26, 2015 |
| Received | Jan 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2018 | Sofradim Production Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M
The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wa Terminated |
FTL | None listed |
| Mar 15, 2018 | Covidien LLC LigaSure" Exact Dissector Nano Coated 20.6mm-21cm
Product Usage:
A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundl Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.