Glostrup, DK · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2024-08-22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2023-04-26 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2022-09-02 |
| HIH | Hysteroscope (And Accessories) | Class II | Obstetrics/Gynecology | 1 | 2020-01-17 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-08-22 | K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | FAJ | Class II | Gastroenterology, Urology |
| 2023-04-26 | K223932 | SafeAir combi (SFR-combi-US) | GEI | Class II | General, Plastic Surgery |
| 2022-09-02 | K221085 | LiNA OperaScope Needle | FBK | Class II | Gastroenterology, Urology |
| 2020-01-17 | K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | HIH | Class II | Obstetrics/Gynecology |