Cleared Special

NovoSorb Matrix

K221686 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery
Sep 2022
Decision
97d
Days
—
Risk

About This 510(k) Submission

K221686 is an FDA 510(k) clearance for the NovoSorb Matrix, a Absorbable Synthetic Wound Dressing, submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on September 15, 2022, 97 days after receiving the submission on June 10, 2022. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K221686 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2022
Decision Date September 15, 2022
Days to Decision 97 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

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.