The following data is part of a De Novo classification by Revmedx, Inc. with the FDA for Xstat.
| DeNovo ID | DEN130016 |
| Device Name: | XSTAT |
| Classification | Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Applicant | REVMEDX, INC. 555 13th Street Nw Washington, DC 20004 |
| Contact | John J Smith |
| Product Code | PGZ |
| CFR Regulation Number | 878.4452 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K130218 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2013-01-30 |
| Decision Date | 2014-04-03 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |