21 CFR 876.3630 — Prosthesis, Penile
Gastroenterology, Urology (GU) · Subpart D—Prosthetic Devices · § 876.3630
Identification
A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.
Classification Rationale
Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FAE | Prosthesis, Penile | 2 | 32 | Implant |
| FTQ | Prosthesis, Penis, Rigid Rod | 2 | 2 | Implant |
Special Controls
FAE — Prosthesis, Penile
The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”
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