K193583 is an FDA 510(k) clearance for the Restrata?. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 25, 2020, 277 days after receiving the submission on December 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application..
| 510(k) Number | K193583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | September 25, 2020 |
| Days to Decision | 277 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSZ — Absorbable Synthetic Wound Dressing |
| Device Class | — |
| Definition | Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application. |