K200767 is an FDA 510(k) clearance for the SilverStream Gel, a Dressing, Wound, Drug, submitted by Enzysurge , Ltd. (Rosh Ha'Ayin, IL). The FDA issued a Cleared decision on October 8, 2020, 197 days after receiving the submission on March 25, 2020. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K200767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2020 |
| Decision Date | October 08, 2020 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |