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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K161805
Device Name EnCor MRI Introducer Set, EnCor Probe Introducer
Applicant
Senorx, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact SARAH MCCARTNEY
Correspondent
Senorx, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact SARAH MCCARTNEY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/01/2016
Decision Date 07/19/2016
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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