Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia

The Food and Drug Administration (FDA, Agency, or we) is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporarily- placed urethral opening system for symptoms of benign prostatic hyperplasia's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.