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510(k) K183503

EasyMark Tissue Marker by Inrad, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2019
Date Received
December 17, 2018
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 Inrad, Inc.

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  • K112945 — ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 1 (November 3, 2011)
  • K093399 — PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018 (November 19, 2009)
  • K093256 — SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 99 (November 17, 2009)
  • K090611 — REVOLUTION FULL CORE BIOPSY (June 4, 2009)
  • K063238 — ULTRACLIP II WING AND ULTRACLIP II COIL (January 30, 2007)
  • K042341 — ULTRACLIP II US (September 20, 2004)
  • K041201 — ULTRACLIP II MR (June 3, 2004)
  • K000612 — ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE (April 24, 2000)

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  • 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)