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510(k) K253530

Trexon™ Monofilament Synthetic Absorbable Suture by Medtronic — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
November 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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