510(k) K040959 ยท FAE Prosthesis, Penile
MENTOR GENESIS PENILE PROSTHESIS
| Applicant | Mentor Corp., Santa Barbara CA, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Apr 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2015 | Coloplast Manufacturing US, LLC Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.
Product Usage:
The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be impla Terminated |
FAE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.