K242192
- 510(k) number
- K242192
- Device name
- Disposable Sphincterotome
- Applicant
- Beijing Zksk Technology Co., Ltd. CN
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-02-06
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242192.pdf
Official FDA record: K242192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.