Home / 510(k) Clearances / K013462

510(k) K013462

HYDROFERA BACTERIOSTATIC WOUND DRESSING by Hydrofera, LLC — Product Code FRO

K013462 is an FDA 510(k) premarket notification submitted by Hydrofera, LLC for the device "HYDROFERA BACTERIOSTATIC WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on January 11, 2002. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Hydrofera, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2002
Date Received
October 18, 2001
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 Hydrofera, LLC

  • K190268 — Hydrofera Blue READY - Border (November 6, 2019)
  • K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (January 2, 2014)
  • K023138 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 17, 2003)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K974313 — HYDROFERA SURGICAL SPEAR (March 2, 1998)
  • K974316 — HYDROFERA FEMORAL WICK (February 13, 1998)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • 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)

FDA data resources