K231405
- 510(k) number
- K231405
- Device name
- Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
- Applicant
- Jiangsu Rong FU Kang Medical Instruments Co., Ltd. CN
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-01-18
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K231405.pdf
Official FDA record: K231405
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.