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510(k) K242128

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) by Xaga Surgical — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2025
Date Received
July 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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