Aurie System— 510(k) DEN250023
UnknownCathbuddy, Inc.
FDA 510(k) clearance DEN250023 for Aurie System, Unknown on 2026-04-30. Applicant: Cathbuddy, Inc.. Device class: 2.
Summary
Cathbuddy's Aurie System is filed under product code SHV (Reusable Intermittent Urinary Catheter System). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.5120. Gastroenterology and Urology is both the classification panel and the review panel. The record lists the submission type as Direct.
Cathbuddy filed from Syracuse, New York. The decision came 328 calendar days after FDA received it (June 6, 2025 to April 30, 2026).
Clearance details
- Applicant
- Cathbuddy, Inc.
- Product code
- Product code SHV
- Device class
- Class 2
- Regulation
- 21 CFR 876.5120
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Syracuse, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.