DEN130016 is an FDA 510(k) submission for the XSTAT. This device is classified as a Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use (Class II - Special Controls, product code PGZ).
Submitted by Revmedx, Inc. (Washington, US). The FDA issued a Not Cleared (DENG) decision on April 3, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4452. To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired..
| 510(k) Number | DEN130016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 30, 2013 |
| Decision Date | April 03, 2014 |
| Days to Decision | 428 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | PGZ - Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4452 |
| Definition | To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired. |