Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
The Protective Coating for the Rectal Mucosa is a mucoadhesive device intended for the protective coating of the rectal mucosal surface. It is classified as "Unclassified" (Class U) by the FDA, meaning it has been cleared via 510(k) but has not been formally assigned to a specific device class. The product code is PHN, reviewed by the Gastroenterology and Urology (GU) panel, with no regulation number or medical specialty formally assigned. This device is not an implant and is not life-sustaining.
Research product code PHN in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PHN
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Mucoadhesive application for the protective coating of the rectal mucosa.
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253923 | PuraStat | Jan 07, 2026 | Substantially Equivalent | 3-D Matrix Europe SAS |
| K242634 | PuraStat | Jan 15, 2025 | Substantially Equivalent | 3-D Matrix Europe SAS |
| K213552 | PuraStat-RM | Apr 01, 2022 | Substantially Equivalent | 3-D Matrix, Inc. |
| K140558 | PROCTIGARD | Jul 16, 2014 | Substantially Equivalent | Access Pharmaceuticals, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.