FDA Product Code
FDA Product Code QNE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4330
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN200016 | EndoRotor Device | Interscope, Inc. | 2020-12-23 | Direct | — |
Product code QNE · Class II · Gastroenterology, Urology. Data: openFDA.