SureTome SW Sphincterotome with DomeTip— 510(k) K251104

Substantially Equivalent

Wilson-Cook Medical

FDA 510(k) clearance K251104 for SureTome SW Sphincterotome with DomeTip, Substantially Equivalent on 2025-09-29. Applicant: Wilson-Cook Medical.

Clearance details

Applicant: Wilson-Cook Medical
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-11
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.