K112191 is an FDA 510(k) clearance for the HEALEX BIOSPONGE WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Bionova Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on June 5, 2012, 312 days after receiving the submission on July 29, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K112191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2011 |
| Decision Date | June 05, 2012 |
| Days to Decision | 312 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 | - |