Device |
prosthesis, penis, rigid rod |
Regulation Description |
Penile rigidity implant. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | FTQ |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.3630
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |
|
|