Kennesaw, GA, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 2 | 2025-01-31 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Class II | Radiology | 2 | 2024-06-26 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | Class II | Gastroenterology, Urology | 2 | 2023-02-22 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 1 | 2022-07-27 |
| FAS | Electrode, Electrosurgical, Active, Urological | Class II | Gastroenterology, Urology | 1 | 2021-05-19 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-31 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | FED | Class II | Gastroenterology, Urology |
| 2024-06-26 | K233380 | TRIDENT Mobile Fluoroscopy System | JAA | Class II | Radiology |
| 2023-02-22 | K221903 | Delta III Pro | LNS | Class II | Gastroenterology, Urology |
| 2022-07-27 | K213252 | Dornier Thulio | GEX | Class II | General, Plastic Surgery |
| 2022-04-18 | K220871 | Nautilus | JAA | Class II | Radiology |
| 2021-05-19 | K210394 | Electrosurgical accessory | FAS | Class II | Gastroenterology, Urology |
| 2020-11-20 | K201815 | Dornier MAGELLAN Ureteral Access Sheath | FED | Class II | Gastroenterology, Urology |
| 2020-09-03 | K201074 | Delta III Lithotripter | LNS | Class II | Gastroenterology, Urology |