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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 K203141
Device Name Uramix CuraWay Biopsy Needle
Applicant
Uramix, Inc.
272 N. Lansdowne Ave.
Lansdowne,  PA  19050
Applicant Contact Michael Mooreville
Correspondent
Uramix, Inc.
272 N. Lansdowne Ave.
Lansdowne,  PA  19050
Correspondent Contact Michael Mooreville
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/20/2020
Decision Date 09/17/2021
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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