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510(k) K243642

UltraCor™ Twirl™ Breast Tissue Marker by Bard Peripheral Vascular, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2025
Date Received
November 26, 2024
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

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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)
  • K251748 — MammoSTAR Biopsy Site Identifier (July 23, 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)