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510(k) K212423

EndoDrill® Model X by Bibbinstruments AB — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2023
Date Received
August 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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