Submission Details
| 510(k) Number | K242149 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 2024 |
| Decision Date | March 05, 2025 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
NovoSorb? MTX
Mar 2025
Decision
225d
Days
—
Risk
About This 510(k) Submission
K242149 is an FDA 510(k) clearance for the NovoSorb? MTX, a Absorbable Synthetic Wound Dressing, submitted by Polynovo Biomaterials Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on March 5, 2025, 225 days after receiving the submission on July 23, 2024. This device falls under the General & Plastic Surgery review panel.
Device Classification
| 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. |
Manufacturer
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