Related Experiment Video
Updated: Apr 14, 2026

Author Spotlight: Enhanced Urodynamic Method for Precise Urine Measurement in Awake Mice with Neurogenic Bladder
Published on: June 7, 2024
Medical devices; gastroenterology-urology devices; classification of the urethral insert with pump for bladder
Abstract:
The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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