Clearance Summary
CiRX Single use electrosurgical pencil with non-coated and coated electrode received FDA 510(k) clearance under submission number K213786, sponsored by Ningbo Shun YE Medical Company, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-06-27.
- Submission: K213786
- Applicant / Sponsor: Ningbo Shun YE Medical Company, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2022-06-27
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.