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PHN — Protective Coating, Mucoadhesive Application, For The Rectal Mucosa Class U

FDA Device Classification

Classification Details

Product Code
PHN
Device Class
Class U
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Definition

Mucoadhesive application for the protective coating of the rectal mucosa.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K2539233-d matrix europePuraStatJanuary 7, 2026
K2426343-d matrix europePuraStatJanuary 15, 2025
K2135523-d matrixPuraStat-RMApril 1, 2022
K140558access pharmaceuticalsPROCTIGARDJuly 16, 2014