510(k) DEN250023 ยท SHV Reusable Intermittent Urinary Catheter System
Aurie System
| Applicant | Cathbuddy, Inc., Syracuse NY, US |
| Decision | Unknown, Apr 30, 2026 |
| Received | Jun 6, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250023
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.