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510(k) K244018

Disposable Biopsy Needle by Zhejiang Curaway Medical Technology Co., Ltd. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
December 27, 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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