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510(k) K231937

Foundation Dermal Regeneration Scaffold (DRS) Solo by Bionova Medical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2023
Date Received
June 30, 2023
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.

  • K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (October 31, 2024)
  • K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (August 21, 2024)
  • K210949 — Foundation Dermal Regeneration Scaffold (DRS) Solo (August 11, 2022)
  • K123961 — SENTREX BIOSPONGE MPD (April 5, 2013)
  • K112191 — HEALEX BIOSPONGE WOUND DRESSING (June 5, 2012)

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)
  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (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)