All Products
United States regulatory status
Rigicon products are distributed in a number of countries. Regulatory status and availability differ from country to country. This page describes the status in the United States only.
Products not available for sale in the United States
Infla10®, Infla2P™, ContiReflex®, ContiClassic® and Testi10™ are not available for sale in the United States.
Rigi10™ Malleable Penile Prosthesis
The Rigi10™ Malleable Penile Prosthesis is available in the United States in 9, 10, 11, 12 and 13 mm diameters. The 14 mm size is not available for sale in the United States.
Infla10® — investigational in the United States
CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.
In the United States, the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis is an investigational device. It is being evaluated in the UNITED study, a prospective, multicenter, single-arm study conducted under an FDA-approved Investigational Device Exemption (IDE). ClinicalTrials.gov identifier: NCT07273773.
The device is not approved by the FDA for commercial distribution in the United States. No conclusion about its safety or effectiveness for the use under investigation can be drawn until the study is complete and the results have been reviewed by the FDA.
Prescription requirement
Federal law (USA) restricts this device to sale by or on the order of a physician.
For the United States
Information intended for the United States is published at www.rigicon.us.