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510(k) K243095

Mammotome AutoCore™ Single Insertion Core Biopsy System by Devicor Medical Products, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2024
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K210752 — HydroMARK Breast Biopsy Site Marker (April 14, 2021)
  • K203097 — HydroMARK Breast Biopsy Site Markers (December 16, 2020)
  • K202012 — Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (August 18, 2020)
  • K170803 — HydroMARK Breast Biopsy Site Markers (June 15, 2017)

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