Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode— 510(k) K231405
Substantially EquivalentJiangsu Rong FU Kang Medical Instruments Co., Ltd.
FDA 510(k) clearance K231405 for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode, Substantially Equivalent on 2024-01-18. Applicant: Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Rong FU Kang Medical Instruments Co., Ltd.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiangyin, CN
Recent devices under product code GEI
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.