K172140 is an FDA 510(k) clearance for the NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm). This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on August 11, 2017, 25 days after receiving the submission on July 17, 2017.
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 | K172140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2017 |
| Decision Date | August 11, 2017 |
| Days to Decision | 25 days |
| Submission Type | Special |
| 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. |