MENTOR MODIFIED MALLEABLE PENILE PROSTHESES

K900371 · Mentor Corp. · FAE · Nov 2, 1990 · Gastroenterology, Urology

Device Facts

• Record ID: K900371
• Device Name: MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
• Applicant: Mentor Corp.
• Product Code: FAE · Gastroenterology, Urology
• Decision Date: Nov 2, 1990
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.3630
• Device Class: Class 2

Regulatory Classification

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.

Special Controls

The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”