PHN · Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
· Class U
Overview
| Product Code | PHN |
|---|---|
| Device Name | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Device Class | Class U |
| Review Panel |
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 | PuraStat | 3-D Matrix Europe SAS | Jan 7, 2026 | SESE |
| K242634 | PuraStat | 3-D Matrix Europe SAS | Jan 15, 2025 | SESE |
| K213552 | PuraStat-RM | 3-D Matrix, Inc. | Apr 1, 2022 | SESE |
| K140558 | 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
