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510(k) K202012

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System by Devicor Medical Products, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2020
Date Received
July 21, 2020
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

Other clearances by Devicor Medical Products, Inc.

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  • K232615 — LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Mark (January 12, 2024)
  • K221961 — HydroMARK Plus Breast Biopsy Site Marker (July 13, 2023)
  • 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)
  • K170803 — HydroMARK Breast Biopsy Site Markers (June 15, 2017)

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