DEN250023
- 510(k) number
- DEN250023
- Device name
- Aurie System
- Applicant
- Cathbuddy, Inc. NY · US
- Product code
- SHV — Reusable Intermittent Urinary Catheter System
- Decision date
- 2026-04-30
- Date received
- 2025-06-06
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Gastroenterology, Urology
Official FDA record: DEN250023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.