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)

FDA 510(k) K172140 · Polynovo Biomaterials Pty, Ltd.

Substantially Equivalent

510(k) numberK172140

Submission

Device name
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)
Applicant
Polynovo Biomaterials Pty, Ltd.
Port Melbourne, AU
Received
July 17, 2017
Decision date
August 11, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QSZ – Absorbable Synthetic Wound Dressing
Device class
Unclassified

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Other 510(k)s with product code QSZ

510(k)DeviceApplicantDecision
K261311HyalomatrixQSZ · Traditional Anika Therapeutics, Inc.09/02/2026SE
K254256LUOFUCON® Wound MatrixQSZ · Traditional Huizhou Foryou Medical Devices Co., Ltd.08/18/2026SE
K260020Redermo Wound MatrixQSZ · Traditional Beijing Kreate Medical Co., Ltd.04/16/2026SE
K251567NovoSorb BTMQSZ · Special Polynovo Biomaterials Pty, Ltd.06/20/2025SE
K242149NovoSorb® MTXQSZ · Traditional Polynovo Biomaterials Pty, Ltd.03/05/2025SE
K241660SiOxD® Wound MatrixQSZ · Special Sioxmed, LLC07/05/2024SE
K232847SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC12/18/2023SE
K223725Restrata® MiniMatrixQSZ · Traditional Acera Surgical, Inc.05/18/2023SE
K222189SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC11/18/2022SE
K221686NovoSorb MatrixQSZ · Special Polynovo Biomaterials Pty, Ltd.09/15/2022SE

More from Polynovo Biomaterials Pty, Ltd.

510(k)DeviceDecision
K251567NovoSorb BTMQSZ · Special 06/20/2025SE
K242149NovoSorb® MTXQSZ · Traditional 03/05/2025SE
K221686NovoSorb MatrixQSZ · Special 09/15/2022SE
K142879BTM Wound DressingQSZ · Traditional 12/23/2015SE
K132936Novopore DressingOMP · Traditional 03/04/2014SE

Questions and answers

When was 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) cleared by the FDA?

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) received a 510(k) decision of Substantially Equivalent on August 11, 2017, 25 days after the submission was received.

What is the product code of K172140?

The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.