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510(k) K051647

FORTADERM ANTIMICROBIAL WOUND DRESSING by Organogenesis, Inc. — Product Code FRO

K051647 is an FDA 510(k) premarket notification submitted by Organogenesis, Inc. for the device "FORTADERM ANTIMICROBIAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Nov 8, 2005. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Organogenesis, Inc. has 11 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 8, 2005
Date Received
Jun 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Organogenesis, Inc.

  • K212579 — FortiShield (Biosynthetic Wound Matrix) (May 2, 2023)
  • K220317 — PuraPly Micronized Wound Matrix (PuraPly MZ) (Jul 1, 2022)
  • K071555 — FORTAGEN ORAL MEMBRANE (Aug 30, 2007)
  • K042809 — CUFFPATCH (Nov 2, 2004)
  • K021107 — FORTAFLEX SURGICAL SLING (May 15, 2002)
  • K021105 — FORTAFLEX SURGICAL MESH (May 10, 2002)
  • K020049 — FORTAFLEX SURGICAL MESH (Mar 18, 2002)
  • K011025 — FORTAFLEX SURGICAL MESH (Aug 24, 2001)
  • K011026 — FORTADERM WOUND DRESSING (Jun 13, 2001)
  • K011027 — FORTAFLEX SURGICAL SLING (May 30, 2001)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (Sep 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (Aug 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (Aug 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (Jun 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (Jun 24, 2026)
  • K261638 — Bonvadis® (Jun 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (Apr 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (Mar 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (Mar 13, 2026)

FDA data resources