Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
FDA product code PHN · Unclassified · Gastroenterology, Urology
Mucoadhesive application for the protective coating of the rectal mucosa.
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261504 | PuraStat-RMPHN · Traditional | 3-D Matrix, Inc. | 08/03/2026SE |
| K253923 | PuraStatPHN · Special | 3-D Matrix Europe SAS | 01/07/2026SE |
| K242634 | PuraStatPHN · Traditional | 3-D Matrix Europe SAS | 01/15/2025SE |
| K213552 | PuraStat-RMPHN · Traditional | 3-D Matrix, Inc. | 04/01/2022SE |
| K140558 | ProctigardPHN · Traditional | Access Pharmaceuticals, Inc. | 07/16/2014SE |