Home / 510(k) Clearances / K241660

510(k) K241660

SiOxD® Wound Matrix by Sioxmed, LLC — Product Code QSZ

K241660 is an FDA 510(k) premarket notification submitted by Sioxmed, LLC for the device "SiOxD® Wound Matrix". The FDA issued a decision of Substantially Equivalent on July 5, 2024. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Sioxmed, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2024
Date Received
June 10, 2024
Clearance Type
Special
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 Sioxmed, LLC

  • K250890 — SBC1 Cream (January 12, 2026)
  • K242406 — SiOxC Cream (March 13, 2025)
  • K232847 — SiOxD Wound Matrix (December 18, 2023)
  • K222189 — SiOxD Wound Matrix (November 18, 2022)

Other clearances for product code QSZ

  • K260020 — Redermo Wound Matrix (April 16, 2026)
  • K251567 — NovoSorb BTM (June 20, 2025)
  • K242149 — NovoSorb® MTX (March 5, 2025)
  • 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)

FDA data resources