Class Class II

SureTome™ SW Sphincterotome with DomeTip (K251104)

K251104 2025-09-29 Traditional
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Description

SureTome™ SW Sphincterotome with DomeTip by Wilson-Cook Medical, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251104
Clearance Date2025-09-29
Clearance TypeTraditional
Product CodeKNS
Regulation Number876.4300

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