# PHN · Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/PHN

## Overview

- **Product Code:** PHN
- **Device Name:** Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Identification

Mucoadhesive application for the protective coating of the rectal mucosa.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253923](/device/K253923.md) | PuraStat | 3-D Matrix Europe SAS | Jan 7, 2026 | SESE |
| [K242634](/device/K242634.md) | PuraStat | 3-D Matrix Europe SAS | Jan 15, 2025 | SESE |
| [K213552](/device/K213552.md) | PuraStat-RM | 3-D Matrix, Inc. | Apr 1, 2022 | SESE |
| [K140558](/device/K140558.md) | PROCTIGARD | Access Pharmaceuticals, Inc. | Jul 16, 2014 | SESE |

## Top Applicants

- 3-D Matrix Europe SAS — 2 clearances
- 3-D Matrix, Inc. — 1 clearance
- Access Pharmaceuticals, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/PHN](https://fda.innolitics.com/productcode/PHN)

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