Portsmouth, NH, US · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2024-08-27 |
| FFX | System, Gastrointestinal Motility (Electrical) | Class II | Gastroenterology, Urology | 1 | 2024-05-06 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | Class II | Gastroenterology, Urology | 1 | 2024-04-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-08-27 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | FBK | Class II | Gastroenterology, Urology |
| 2024-05-06 | K240007 | Solar Compact (G4-1) | FFX | Class II | Gastroenterology, Urology |
| 2024-04-23 | K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | KLA | Class II | Gastroenterology, Urology |