PHN
5 FDA 510(k) clearances · Product code
133 daysmedian time to decision
144 days90th percentile
5clearances measured
FDA profile
- Official device name
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Device class
- Unclassified
- Medical specialty
- Unknown
- FDA definition
- Mucoadhesive application for the protective coating of the rectal mucosa.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PuraStat-RM (K261504) | 3-D Matrix, Inc. | 2026-08-03 |
| PuraStat (K253923) | 3-D Matrix Europe SAS | 2026-01-07 |
| PuraStat (K242634) | 3-D Matrix Europe SAS | 2025-01-15 |
| PuraStat-RM (K213552) | 3-D Matrix, Inc. | 2022-04-01 |
| PROCTIGARD (K140558) | Access Pharmaceuticals, Inc. | 2014-07-16 |
Track PHN automatically
Every clearance here is in the API, with alerts when new ones post.