K230589 is an FDA 510(k) clearance for the Celox Rapid X-Ray Gauze. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on November 17, 2023, 260 days after receiving the submission on March 2, 2023.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K230589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2023 |
| Decision Date | November 17, 2023 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |