inforMED
SHVClass II

Reusable Intermittent Urinary Catheter System

Gastroenterology, Urology · 21 CFR 876.5120

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.

MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time

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Recalls

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No recalls on file for this product code.

Registered firms

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No registered firms found for this product code.

510(k) clearances

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