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510(k) K252892

SCOUT MD Surgical Guidance System by Merit Medical Systems, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
September 11, 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

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