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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 K242128
Device Name Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
Applicant
Xaga Surgical
Alnarpsgatan 81
Helsingborg,  SE SE-256 67
Applicant Contact Anders Grim
Correspondent
Xaga Surgical
lliongränden 320
Lund,  SE SE-224 71
Correspondent Contact Michael Lundh
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/19/2024
Decision Date 02/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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