Panels › Gastroenterology, Urology › Product code FAE · Class 2
Prosthesis, Penile
Regulation 876.3630
0510(k)s in 12 months (32 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in FAE
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems, Inc. | 11 | 2 |
| Dacomed Corp. | 7 | 0 |
| Mentor Corp. | 5 | 0 |
| Medical Engineering Corp. | 2 | 0 |
| American Medical Corp. | 1 | 0 |
| Boston Scientific Corporation | 1 | 0 |
| Burditt & Calkins-Siemens-Elema | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Coloplast Manufacturing US, LLC | 0 | 1 |
| Rigicon, Inc. | 1 | 0 |
| 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 | K040959 |
| Apr 3, 2007 | American Medical Systems AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | K953640 |
| Apr 3, 2007 | American Medical Systems AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | K953640 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.