K233151 is an FDA 510(k) clearance for the PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC). This device is classified as a Dressing, Wound, Drug.
Submitted by Medline Industries, LP (Northfiled, 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 FDA review panel.
| 510(k) Number | K233151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 | — |