Daegu, KR · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FCG | Biopsy Needle | Class II | Gastroenterology, Urology | 2 | 2025-08-21 |
| OCX | — | — | — | 2 | 2024-08-20 |
| KTI | Bronchoscope Accessory | Class II | Ear, Nose, Throat | 1 | 2026-04-16 |
| KGE | Forceps, Biopsy, Electric | Class II | Gastroenterology, Urology | 1 | 2025-05-21 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2020-10-05 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-16 | K251478 | ClearTip TBNA Type | KTI | Class II | Ear, Nose, Throat |
| 2025-08-21 | K250994 | ClearTip FNA and FNB Types | FCG | Class II | Gastroenterology, Urology |
| 2025-05-21 | K242857 | ClearHemograsper | KGE | Class II | Gastroenterology, Urology |
| 2024-08-20 | K242134 | ClearCap Distal Attachment | OCX | — | — |
| 2023-06-30 | K231267 | ClearTip | FCG | Class II | Gastroenterology, Urology |
| 2021-02-19 | K202616 | ClearCap Distal Attachment | OCX | — | — |
| 2020-10-05 | K200217 | ClearEndoclip | PKL | Class II | Gastroenterology, Urology |