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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 K210654
Device Name EnCor Breast Biopsy Probe with Rinse Tube
Applicant
Senorx, Inc.
1625 W. 3rd St.
Tempe,  AZ  85251
Applicant Contact Jessica Myer
Correspondent
Senorx, Inc.
1625 W. 3rd St.
Tempe,  AZ  85251
Correspondent Contact Jessica Myer
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/04/2021
Decision Date 03/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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