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510(k) K212158

HydroMARK Breast Biopsy Site Marker by Devicor Medical Products, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2022
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Devicor Medical Products, Inc.

  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K253761 — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Bre (January 23, 2026)
  • K243095 — Mammotome AutoCore™ Single Insertion Core Biopsy System (October 29, 2024)
  • K240527 — HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (July 10, 2024)
  • 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)
  • 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)

Other clearances for product code NEU

  • K253761 — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Bre (January 23, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) (December 12, 2025)
  • K251748 — MammoSTAR Biopsy Site Identifier (July 23, 2025)
  • K243642 — UltraCor™ Twirl™ Breast Tissue Marker (March 24, 2025)
  • K233639 — SmartClip Secure Soft Tissue Marker (December 20, 2024)
  • K240429 — Trilogy Tissue Marker (November 7, 2024)
  • K234149 — MOLLI 2 System (September 26, 2024)
  • K240042 — MOLLI 2 System (September 25, 2024)