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510(k) K251748

MammoSTAR Biopsy Site Identifier by Carbon Medical Technologies, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2025
Date Received
June 6, 2025
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 Carbon Medical Technologies, Inc.

  • K211590 — Fiducial Marker (June 10, 2021)
  • K191797 — BiomarC Fiducial Marker (July 29, 2019)
  • K172227 — Endoscopic Injection Needle (August 23, 2017)
  • K133148 — BIOMARC COAXIAL NEEDLE (May 13, 2014)
  • K132064 — BIOMARC FIDUCIAL MARKER (February 28, 2014)
  • K132708 — BIOMARC FIDUCIAL MARKER (December 20, 2013)
  • K130678 — BIOMARC GOLD FIDUCIAL MARKER (April 12, 2013)
  • K110772 — BIOMARC FIDUCIAL MARKER (April 28, 2011)
  • K100994 — PRELOADED TISSUE MARKER DEVICE (April 30, 2010)
  • K070436 — BIOMARC GOLD TISSUE MARKER (March 16, 2007)

Other clearances for product code NEU

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  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) (December 12, 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)
  • K241762 — OneMark (September 16, 2024)