K231615
- 510(k) number
- K231615
- Device name
- Disposable Endoscopic Bipolar
- Applicant
- Jiangsu Hope Biomedical Science & Technology Co., Ltd. CN
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-12-05
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231615.pdf
Official FDA record: K231615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.