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510(k) K242149

NovoSorb® MTX by Polynovo Biomaterials Pty, Ltd. — Product Code QSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2025
Date Received
July 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Synthetic Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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 clearances by Polynovo Biomaterials Pty, Ltd.

  • K251567 — NovoSorb BTM (June 20, 2025)
  • K221686 — NovoSorb Matrix (September 15, 2022)
  • K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10c (August 11, 2017)
  • K142879 — BTM Wound Dressing (December 23, 2015)
  • K132936 — NOVOPORE DRESSING (March 4, 2014)

Other clearances for product code QSZ

  • K251567 — NovoSorb BTM (June 20, 2025)
  • K241660 — SiOxD® Wound Matrix (July 5, 2024)
  • K232847 — SiOxD Wound Matrix (December 18, 2023)
  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K222189 — SiOxD Wound Matrix (November 18, 2022)
  • K221686 — NovoSorb Matrix (September 15, 2022)
  • K193583 — Restrata® (September 25, 2020)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)
  • K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10c (August 11, 2017)
  • K170213 — SupraSDRM Biodegradable Matrix Wound Dressing (June 28, 2017)