Cleared Special

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)

K172140 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery

Aug 2017

Decision

25d

Days

—

Risk

About This 510(k) Submission

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), 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 review panel.

Submission Details

510(k) Number	K172140 FDA.gov
FDA Decision	Cleared 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

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.