FDA Product Code
FDA Product Code FAN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | Surgease Innovations Limited | 2023-11-30 | Traditional | PDF ↗ |
| K831788 | URODYNAMIC ANALYZER | C.R. Bard, Inc. | 1983-09-12 | Traditional | PDF ↗ |
Product code FAN · Class II · Gastroenterology, Urology. Data: openFDA.