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510(k) K193583

Restrata® by Acera Surgical, Inc. — Product Code QSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
December 23, 2019
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 Acera Surgical, Inc.

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K170300 — Restrata Wound Matrix (April 26, 2017)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)

Other clearances for product code QSZ

  • K251567 — NovoSorb BTM (June 20, 2025)
  • K242149 — NovoSorb® MTX (March 5, 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)
  • 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)