21 CFR 876.5120 — Reusable Intermittent Urinary Catheter System

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5120

Identification

The Aurie Reusable No-Touch Intermittent Catheter System (or Aurie System) is a reusable intermittent urinary catheter system indicated for the drainage of urine from the bladder for adult males requiring intermittent catheterization. The system consists of a reusable intermittent urinary catheter inserted through the urethra into the bladder for urine drainage and the components necessary to reprocess the intermittent catheter. It is intended for single patient reuse and must be cleaned, high-level disinfected, and lubricated with the Aurie Personal Washer-Disinfection prior to use. The system may include cleaning and microbicidal agents, lubricant, and disposable components.

Classification Rationale

The FDA concludes that this device should be classified into Class II. The FDA has determined that, for the stated indications for use, the Aurie System can be classified in class II with the establishment of special controls for class II, which provide reasonable assurance of the safety and effectiveness of the device type.

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