Home / 510(k) Clearances / K240298

510(k) K240298

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo by Bionova Medical, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2024
Date Received
February 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
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)
  • K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo (November 13, 2023)
  • 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 FRO

  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)