K193552 is an FDA 510(k) clearance for the InnovaMatrix. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Triad Life Sciences, Inc. (Memphis, US). The FDA issued a Cleared decision on October 21, 2020, 306 days after receiving the submission on December 20, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K193552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2019 |
| Decision Date | October 21, 2020 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |