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510(k) K232865

Magseed Pro Magnetic Marker System by Endomagnetics Ltd., — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2024
Date Received
September 15, 2023
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 Endomagnetics Ltd.,

  • K222832 — Sentimag System (January 21, 2023)
  • K173587 — Magseed Magnetic Marker Systtem (February 16, 2018)
  • K163541 — Magseed Magnetic Marker System (January 13, 2017)
  • K153044 — Sentimag System, Sentimark Magnetic Marker Systerm (March 2, 2016)

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