K190756 is an FDA 510(k) clearance for the IODOFLEX, a Dressing, Wound, Drug, submitted by Smith & Nephew Medical, Ltd. (Hull East Riding Of Yorkshire, GB). The FDA issued a Cleared decision on December 20, 2019, 270 days after receiving the submission on March 25, 2019. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K190756 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |