Cleared Traditional

K242634 - PuraStat (FDA 510(k) Clearance)

K242634 · 3-D Matrix Europe SAS · Gastroenterology & Urology device
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Jan 2025
Decision
134d
Days
-
Risk

K242634 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 15, 2025 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K242634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date January 15, 2025
Days to Decision 134 days
Submission Type Traditional
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
4d slower than avg
Panel avg: 130d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

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.