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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K243568
Device Name Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact Lindsey Ebke
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact Lindsey Ebke
Regulation Number876.4300
Classification Product Code
KNS  
Date Received11/18/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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