510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253923Substantially Equivalent

PuraStat

3-D Matrix Europe SAS, Caluire Et Cuire, FR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253923 is the FDA 510(k) clearance record for PuraStat, cleared for 3-D Matrix Europe SAS on under FDA product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa). FDA's definition for product code PHN reads: "Mucoadhesive application for the protective coating of the rectal mucosa". FDA records list 4 510(k) clearances for 3-D Matrix Europe SAS, from to . As of , FDA records show no recalls naming K253923.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device class
Unclassified
Review panel
Unknown
Applicant
3-D Matrix Europe SAS 11 Chemin Des Petites Brosses, Caluire Et Cuire, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHN

Trailing 12 months
2 clearances under product code PHN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260