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510(k) K233639

SmartClip Secure Soft Tissue Marker by Elucent Medical, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
November 13, 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 Elucent Medical, Inc.

  • K183400 — EnVisio Navigation Sytem (March 22, 2019)
  • K180640 — SmartClip Soft Tissue Marker (June 4, 2018)

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