Aurie System
FDA 510(k) clearance DEN250023 · decided 2026-04-30
Clearance details
- K-number
- DEN250023
- Device name
- Aurie System
- Applicant
- Cathbuddy, Inc.
- Decision
- Unknown
- Date received
- 2025-06-06
- Decision date
- 2026-04-30
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- SHV
- Device class
- 2
- Regulation number
- 876.5120
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Syracuse, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.