PHN
- Product code
- PHN
- Device name
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
FDA classification definition
Mucoadhesive application for the protective coating of the rectal mucosa.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261504 | 2026-08-03 | 3-D Matrix, Inc. | PuraStat-RM | |
| K253923 | 2026-01-07 | 3-D Matrix Europe SAS | PuraStat | |
| K242634 | 2025-01-15 | 3-D Matrix Europe SAS | PuraStat |
Official FDA classification page: PHN
Classification and pathway per current FDA publications. Data from openFDA (CC0).