510(k) DEN250023

Aurie System by Cathbuddy, Inc. — Product Code SHV

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 30, 2026
Date Received: June 6, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Reusable Intermittent Urinary Catheter System
Device Class: Class II
Regulation Number: 876.5120
Review Panel: GU
Submission Type

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.