PuraStat

FDA 510(k) K253923 · 3-D Matrix Europe SAS

Substantially Equivalent

510(k) numberK253923

Submission

Device name
PuraStat
Applicant
3-D Matrix Europe SAS
Caluire Et Cuire, FR
Received
December 8, 2025
Decision date
January 7, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device class
Unclassified

Mucoadhesive application for the protective coating of the rectal mucosa.

Other 510(k)s with product code PHN

510(k)DeviceApplicantDecision
K261504PuraStat-RMPHN · Traditional 3-D Matrix, Inc.08/03/2026SE
K242634PuraStatPHN · Traditional 3-D Matrix Europe SAS01/15/2025SE
K213552PuraStat-RMPHN · Traditional 3-D Matrix, Inc.04/01/2022SE
K140558ProctigardPHN · Traditional Access Pharmaceuticals, Inc.07/16/2014SE

More from Access Pharmaceuticals, Inc.

510(k)DeviceDecision
K253924PuraStatQAU · Special 01/07/2026SE
K242634PuraStatPHN · Traditional 01/15/2025SE
K242250PuraStatQAU · Traditional 10/22/2024SE

Questions and answers

When was PuraStat cleared by the FDA?

PuraStat (K253923) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 30 days after the submission was received.

What is the product code of K253923?

The FDA product code is PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa, a Unclassified device.