K193085 is an FDA 510(k) clearance for the PuraDERM Gel, a Dressing, Wound, Drug, submitted by 3-D Matrix, Inc. (Needham, US). The FDA issued a Cleared decision on May 11, 2020, 188 days after receiving the submission on November 5, 2019. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K193085 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 2019 |
| Decision Date | May 11, 2020 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |