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510(k) K253923

PuraStat by 3-D Matrix Europe SAS — Product Code PHN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 7, 2026
Date Received: December 8, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device Class: Class U
Regulation Number
Review Panel: GU
Submission Type

Mucoadhesive application for the protective coating of the rectal mucosa.