Emmendingen, DE · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 3 | 2026-02-11 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-06-23 | Class II | Terminated | Z-2744-2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps … | — | The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is la… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-11 | K251813 | CURIS II RF Generator (REF 360100-05) | GEI | Class II | General, Plastic Surgery |
| 2024-01-25 | K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | GEI | Class II | General, Plastic Surgery |
| 2020-02-10 | K193587 | Sutter Swyng non-stick bipolar forceps, single-use | GEI | Class II | General, Plastic Surgery |