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510(k) K123961

SENTREX BIOSPONGE MPD by Bionova Medical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
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 Bionova Medical, Inc.

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  • K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo (November 13, 2023)
  • K210949 — Foundation Dermal Regeneration Scaffold (DRS) Solo (August 11, 2022)
  • K112191 — HEALEX BIOSPONGE WOUND DRESSING (June 5, 2012)

Other clearances for product code KGN

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  • 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)