K223495 is an FDA 510(k) clearance for the Zeolite Hemostatic Cotton. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Hangzhou Zeo-Innov Life Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 2, 2023, 162 days after receiving the submission on November 21, 2022.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K223495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | May 02, 2023 |
| Days to Decision | 162 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. |