# DEN250023: Aurie System

- Pathway: De Novo (Direct)
- Applicant: Cathbuddy, Inc.
- Decided: Apr 30, 2026 after 328 days
- Product code: SHV (Reusable Intermittent Urinary Catheter System)
- Device class: 2
- Regulation: 21 CFR 876.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Aurie Reusable No-Touch Intermittent Catheter System (or Aurie System) is indicated for the drainage of urine from the bladder for adult males requiring intermittent catheterization. Prior to use, the Aurie Catheter must be cleaned, high-level disinfected, and lubricated with the Aurie Personal Washer-Disinfector. It is for single patient reuse.

Source page: https://510kreport.com/device/DEN250023
Methodology: https://510kreport.com/methodology