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510(k) K240753

Miro3D Fibers Wound Matrix by Reprise Biomedical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
March 20, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Reprise Biomedical, Inc.

  • K240277 — MiroDry Wound Matrix (March 1, 2024)
  • K231614 — MiroTract Wound Matrix (December 13, 2023)
  • K223257 — Miro3D Wound Matrix (November 21, 2022)
  • K221520 — Miro3D Wound Matrix (August 18, 2022)

Other clearances for product code KGN

  • K260532 — Derma-Gide (March 19, 2026)
  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
  • K251323 — Device 104 Particulate (January 22, 2026)
  • K253339 — Theracor (December 22, 2025)
  • K252673 — LacertaMatrix (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)