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510(k) K243296

Disposable Biopsy Needle by Carbon (Shenzhen) Medical Device Co., Ltd. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
October 18, 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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