SHV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Reusable Intermittent Urinary Catheter System

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5120

Medical specialty

Gastroenterology, Urology

FDA definition

A reusable intermittent urinary catheter 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. The reusable intermittent urinary catheter can be reused after reprocessing (e.g., cleaning and disinfection) with the components necessary to reprocess the intermittent catheter. The system may include cleaning and microbicidal agents, lubricant and disposable components. The reusable intermittent catheter and any reusable reprocessing components are intended for single patient reuse.

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