510(k) DEN250023
- Device
- Aurie System
- Applicant
- Cathbuddy, Inc.
- 510(k) number
- DEN250023
- Product code
- SHV
- Decision
- Unknown (DENG)
- Decision date
- 2026-04-30
- Date received
- 2025-06-06
- Regulation
- 876.5120
- Classification name
- Reusable Intermittent Urinary Catheter System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Souvik Paul
- Address
- 841 E. Fayette St. Syracuse NY US 13210 13210
Source Documents
510(k) summary PDF not indicated by FDA