K251104
- 510(k) number
- K251104
- Device name
- SureTome SW Sphincterotome with DomeTip
- Applicant
- Wilson-Cook Medical NC · US
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-09-29
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251104.pdf
Official FDA record: K251104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.