FDA Product Code
FDA Product Code SHV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5120
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250023 | Aurie System | Cathbuddy, Inc. | 2026-04-30 | Direct | — |
Product code SHV · Class II · Gastroenterology, Urology. Data: openFDA.