510(k) DEN250023
DEN250023 is an FDA 510(k) premarket notification submitted by Cathbuddy, Inc. for the device "Aurie System". The FDA issued a decision of De Novo Granted on Apr 30, 2026. The device falls under product code SHV (Reusable Intermittent Urinary Catheter System), a Class II device regulated under 21 CFR 876.5120.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 30, 2026
- Date Received
- Jun 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.