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510(k) K152989

Mammotome revolve Dual Vacuum Assist Biopsy System by Devicor Medical Products, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2016
Date Received
October 13, 2015
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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  • K212158 — HydroMARK Breast Biopsy Site Marker (April 21, 2022)
  • 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)

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