PuraStat-RM
FDA 510(k) K261504 · 3-D Matrix, Inc.
510(k) numberK261504
Submission
- Device name
- PuraStat-RM
- Applicant
- 3-D Matrix, Inc.
Newton, MA, US - Received
- May 6, 2026
- Decision date
- August 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Device class
- Unclassified
Mucoadhesive application for the protective coating of the rectal mucosa.
Other 510(k)s with product code PHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Access Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261503 | PuraStat GIQAU · Traditional | 08/03/2026SE |
| K222481 | PuraStatQAU · Traditional | 02/28/2023SE |
| K213552 | PuraStat-RMPHN · Traditional | 04/01/2022SE |
| K210211 | PuraStat-OMOLR · Traditional | 10/08/2021SE |
| K210098 | PuraStat-GIQAU · Traditional | 06/25/2021SE |
| K193085 | PuraDERM GelFRO · Traditional | 05/11/2020SE |
| K183015 | PuraSinusNHB · Traditional | 04/12/2019SE |
| K143058 | PuraDerm GelFRO · Traditional | 02/13/2015SE |
Questions and answers
When was PuraStat-RM cleared by the FDA?
PuraStat-RM (K261504) received a 510(k) decision of Substantially Equivalent on August 3, 2026, 89 days after the submission was received.
What is the product code of K261504?
The FDA product code is PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa, a Unclassified device.