NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10…

FDA 510(k)

U (US FDA 510(k))

510(k) K172140

Identifiers

510(k) Number: K172140 FDA 510(k)
FDA Product Code: QSZ FDA 510(k)

Classification

Device Class: U FDA 510(k)
Advisory Committee: Unknown FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10… by Polynovo Biomaterials Pty, Ltd. — U — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172140	U	Active

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Manufacturer

Manufacturer: Polynovo Biomaterials Pty, Ltd.

Sources (1)

FDA 510(k) K172140 24 fields · synced Jun 18, 2026