K233151 is an FDA 510(k) clearance for the PluroGel? Antimicrobial Burn and Wound Dressing, PluroGel? Burn and Wound Dressing (OTC), a Dressing, Wound, Drug, submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on March 26, 2024, 181 days after receiving the submission on September 27, 2023. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K233151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2023 |
| Decision Date | March 26, 2024 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |