Home / 510(k) Clearances / K222462

510(k) K222462

Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) by Itp Innovative Tomography Products GmbH — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2023
Date Received
August 15, 2022
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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