K211943 is an FDA 510(k) clearance for the Microlyte Ag/Lidocaine. This device is classified as a Dressing, Wound, Drug.
Submitted by Imbed Biosciences (Fitchburg, US). The FDA issued a Cleared decision on October 17, 2024, 1212 days after receiving the submission on June 23, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K211943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2021 |
| Decision Date | October 17, 2024 |
| Days to Decision | 1212 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |