FDA Product Code
FDA Product Code PJH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5930
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150558 | Eclipse System | Pelvalon, Inc. | 2015-11-12 | Traditional | PDF ↗ |
| DEN140020 | ECLIPSE SYSTEM | Pelvalon | 2015-02-12 | Direct | — |
Product code PJH · Class II · Gastroenterology, Urology. Data: openFDA.