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510(k) K253888

MOLLI 2 System by Stryker Endoscopy — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2025
Date Received
December 4, 2025
Clearance Type
Special
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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