K132397 is an FDA 510(k) clearance for the GORE BIO-A WOUND MATRIX. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on May 7, 2014, 279 days after receiving the submission on August 1, 2013.
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 | K132397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2013 |
| Decision Date | May 07, 2014 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| 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. |