K182811 is an FDA 510(k) clearance for the gel-e Flex+. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Gel-E, Inc. (College Park, US). The FDA issued a Cleared decision on August 29, 2019, 330 days after receiving the submission on October 3, 2018.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K182811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2018 |
| Decision Date | August 29, 2019 |
| Days to Decision | 330 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. |