NovoSorb BTM— 510(k) K251567

Name: FDA 510(k) clearance K251567
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Substantially Equivalent

Polynovo Biomaterials Pty, Ltd.

FDA 510(k) clearance K251567 for NovoSorb BTM, Substantially Equivalent on 2025-06-20. Applicant: Polynovo Biomaterials Pty, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Polynovo Biomaterials Pty, Ltd.
Product code: Code QSZ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-05-22
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSZ

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K261311 — HYALOMATRIX2026-09-02
K254256 — LUOFUCON® Wound Matrix2026-08-18
K260020 — Redermo Wound Matrix2026-04-16
K242149 — NovoSorb® MTX2025-03-05
K241660 — SiOxD® Wound Matrix2024-07-05

More clearances from Polynovo Biomaterials Pty, Ltd.

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K221686 — NovoSorb Matrix2022-09-15
K172140 — 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)2017-08-11
K142879 — BTM Wound Dressing2015-12-23
K132936 — NOVOPORE DRESSING2014-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.