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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 K252681
Device Name EnCor EnCompass™ Breast Biopsy and Tissue Removal System
Applicant
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Jessica Meyer
Correspondent
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Jessica Meyer
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/25/2025
Decision Date 12/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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