K162348 is an FDA 510(k) clearance for the ABCcolla Collagen Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Acro Biomedical Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on May 10, 2017, 261 days after receiving the submission on August 22, 2016.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K162348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2016 |
| Decision Date | May 10, 2017 |
| Days to Decision | 261 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 | - |