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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 K173559
Device Name Barrx SB RFA Endoscopic Catheter
Applicant
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Saket Bhatt
Correspondent
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Saket Bhatt
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received11/17/2017
Decision Date 01/18/2018
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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