Daegu, KR · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unclassified | Unknown | 1 | 2024-04-19 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2022-12-21 |
| FDI | Snare, Flexible | Class II | Gastroenterology, Urology | 1 | 2022-11-21 |
| OTJ | Laparoscopic Single Port Access Device | Class II | Gastroenterology, Urology | 1 | 2022-09-28 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2022-06-23 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 1 | 2022-06-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-04-19 | K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | QSY | Unclassified | Unknown |
| 2022-12-21 | K221054 | CORE-INJECTOR | FBK | Class II | Gastroenterology, Urology |
| 2022-11-21 | K220846 | CORE-SNARE | FDI | Class II | Gastroenterology, Urology |
| 2022-09-28 | K220081 | CORE-SPORT | OTJ | Class II | Gastroenterology, Urology |
| 2022-06-23 | K213338 | CORE-CLIP | PKL | Class II | Gastroenterology, Urology |
| 2022-06-21 | K211148 | CORE-Trocar | GCJ | Class II | Gastroenterology, Urology |