K223126 is an FDA 510(k) clearance for the SurgiAid® Collagen Wound Dressing. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Maxigen Biotech, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on October 11, 2023, 373 days after receiving the submission on October 3, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K223126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | October 11, 2023 |
| Days to Decision | 373 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 | - |