K232476
- 510(k) number
- K232476
- Device name
- Disposable Sphincterotome
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd. CN
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2023-11-07
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232476.pdf
Official FDA record: K232476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.