Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
Device Facts
| Record ID | K260466 |
|---|---|
| Device Name | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) |
| Applicant | Zhejiang shuyou Surgical Instrument Co., Ltd. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
