Cleared Special

K253923 - PuraStat (FDA 510(k) Clearance)

K253923 · 3-D Matrix Europe SAS · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
30d
Days
-
Risk

K253923 is an FDA 510(k) clearance for the PuraStat. Classified as Protective Coating, Mucoadhesive Application, For The Rectal Mucosa (product code PHN).

Submitted by 3-D Matrix Europe SAS (Caluire Et Cuire, FR). The FDA issued a Cleared decision on January 7, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3-D Matrix Europe SAS devices

Submission Details

510(k) Number K253923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date January 07, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device Class -
Definition Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa.