Cixi, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OAB | — | — | — | 1 | 2024-10-04 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics/Gynecology | 1 | 2023-03-28 |
| LFL | Instrument, Ultrasonic Surgical | Unclassified | Unknown | 1 | 2022-07-18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2021-10-25 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics/Gynecology | 1 | 2021-10-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-10-04 | K240376 | Electroporation System (N3000) | OAB | — | — |
| 2023-03-28 | K221995 | Gas Insufflator | HIF | Class II | Obstetrics/Gynecology |
| 2022-07-18 | K212614 | Ultrasonic Scalpel System | LFL | Unclassified | Unknown |
| 2021-10-25 | K210488 | Ultrasonic Surgical & Electrosurgical Generator | GEI | Class II | General, Plastic Surgery |
| 2021-10-13 | K210116 | Video Endoscopy System, 3D Video Endoscopy System | HET | Class II | Obstetrics/Gynecology |