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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
510(k) Number K131614
Device Name REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Daniel Campion
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Daniel Campion
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received06/03/2013
Decision Date 08/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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