Bellefonte, PA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FDF | — | — | — | 2 | 2024-10-04 |
| FDS | — | — | — | 1 | 2025-10-31 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General Hospital | 1 | 2022-10-31 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology, Urology | 1 | 2020-12-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-31 | K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | FDS | — | — |
| 2024-10-04 | K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | FDF | — | — |
| 2023-11-03 | K231254 | GripTract-GI Endoscopic Tissue Manipulator | FDF | — | — |
| 2022-10-31 | K220890 | IO Needle Safety Sheath | FMI | Class II | General Hospital |
| 2020-12-04 | K200646 | TubeClear System | KNT | Class II | Gastroenterology, Urology |