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FDA 510(k)

NovoSorb® MTX

K-Number: K242149 · 2025-03-05

ApplicantPolynovo Biomaterials Pty, Ltd.
Decision Date2025-03-05
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

NovoSorb® MTX is the device name listed in this FDA 510(k) record. The listed applicant is Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2025-03-05 under 510(k) number K242149. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoSorb® MTX?

NovoSorb® MTX is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K242149.

When did NovoSorb® MTX receive FDA 510(k) clearance?

NovoSorb® MTX received FDA 510(k) clearance on 2025-03-05, under 510(k) number K242149.

Who is the listed applicant for NovoSorb® MTX?

The FDA 510(k) record lists Polynovo Biomaterials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoSorb® MTX?

The FDA product code for NovoSorb® MTX is QSZ.

Other records listing Polynovo Biomaterials Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251567NovoSorb BTMK221686NovoSorb MatrixK172140NovoSorb 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)

Related Devices (Code: QSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K241660SiOxD® Wound MatrixSioxmed, LLCK232847SiOxD Wound MatrixSioxmed, LLCK223725Restrata® MiniMatrixAcera Surgical, Inc.K222189SiOxD Wound MatrixSioxmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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