FDA product code PHN: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
PHN is the FDA product code for protective coating, mucoadhesive application, for the rectal mucosa. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under PHN, 4 in the last five years, from 3 different applicants. The average 510(k) review took 106 days (median 133); 97 days on average over the last three years.
Definition
Mucoadhesive application for the protective coating of the rectal mucosa.
Classification
| Field | Value |
|---|---|
| Device name | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for PHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 144 |
| 2025 | 1 | 134 |
| 2026 | 2 | 60 |
Compare with all 510(k) review times · Search every PHN clearance
Top PHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3-D Matrix, Inc. | 2 | 2026-08-03 |
| 3-D Matrix Europe SAS | 2 | 2026-01-07 |
| Access Pharmaceuticals, Inc. | 1 | 2014-07-16 |
Most recent PHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261504 | 3-D Matrix, Inc. | PuraStat-RM | 2026-08-03 | 89 |
| K253923 | 3-D Matrix Europe SAS | PuraStat | 2026-01-07 | 30 |
| K242634 | 3-D Matrix Europe SAS | PuraStat | 2025-01-15 | 134 |
| K213552 | 3-D Matrix, Inc. | PuraStat-RM | 2022-04-01 | 144 |
| K140558 | Access Pharmaceuticals, Inc. | PROCTIGARD | 2014-07-16 | 133 |
Recalls for PHN devices
openFDA lists no recalls for product code PHN.
Frequently asked questions
What is FDA product code PHN?
PHN is the FDA product code for protective coating, mucoadhesive application, for the rectal mucosa. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is PHN?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHN?
Across 5 cleared submissions the average was 106 days from receipt to decision (median 133).
Which companies have the most PHN clearances?
3-D Matrix, Inc. (2); 3-D Matrix Europe SAS (2); Access Pharmaceuticals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHN
- Run a recall and safety report across every PHN manufacturer
- Watch product code PHN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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