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510(k) K251104

SureTome™ SW Sphincterotome with DomeTip by Wilson-Cook Medical — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2025
Date Received
April 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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