K232825
- 510(k) number
- K232825
- Device name
- Disposable Sphincterotome
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. CN
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2024-03-29
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K232825.pdf
Official FDA record: K232825
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.