PHN

Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

Product code
PHN
Device name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device class
Class U
Medical specialty
Unknown
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
5 (all years; only the last 3 years are listed here)

FDA classification definition

Mucoadhesive application for the protective coating of the rectal mucosa.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-08-03.

NumberDecision dateApplicantDevice nameSummary
K2615042026-08-033-D Matrix, Inc.PuraStat-RMPDF
K2539232026-01-073-D Matrix Europe SASPuraStatPDF
K2426342025-01-153-D Matrix Europe SASPuraStatPDF

3 summaries are archived here for direct download.

Official FDA classification page: PHN
Classification and pathway per current FDA publications. Data from openFDA (CC0).