K161020 is an FDA 510(k) clearance for the XSTAT-12, 3-Pack, XSTAT-12, 1-Pack. 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. (Wilsonville,, US). The FDA issued a Cleared decision on July 28, 2016, 107 days after receiving the submission on April 12, 2016.
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 | K161020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2016 |
| Decision Date | July 28, 2016 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |