FDA Product Code
FDA Product Code QIR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5861
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN180055 | CARPEDIEM System | Bellco Srl (Now Part of Medtronic, Inc) | 2020-04-29 | Direct | — |
Product code QIR · Class II · Gastroenterology, Urology. Data: openFDA.