K213552 is an FDA 510(k) clearance for the PuraStat-RM. This device is classified as a Protective Coating, Mucoadhesive Application, For The Rectal Mucosa.
Submitted by 3-D Matrix, Inc. (Newton, US). The FDA issued a Cleared decision on April 1, 2022, 144 days after receiving the submission on November 8, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa..
| 510(k) Number | K213552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | April 01, 2022 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PHN - Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Device Class | - |
| Definition | Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa. |