K210128 is an FDA 510(k) clearance for the INTEGRA Wound Matrix (Macro-Channels). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on October 8, 2021, 262 days after receiving the submission on January 19, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K210128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | October 08, 2021 |
| Days to Decision | 262 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 | — |