Clearance Summary
Disposable Endoscopic Bipolar received FDA 510(k) clearance under submission number K231615, sponsored by Jiangsu Hope Biomedical Science & Technology Co., 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 2023-12-05.
- Submission: K231615
- Applicant / Sponsor: Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-12-05
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.