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510(k) K120930

CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING by Medtrade Products , Ltd. — Product Code FRO

K120930 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING". The FDA issued a decision of Substantially Equivalent on October 26, 2012. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
March 27, 2012
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 Medtrade Products , Ltd.

  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K161274 — Bondiloxs Topical Hemostatic Granules (January 18, 2017)
  • K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSING (June 25, 2014)
  • K113560 — CELOX GAUZE PRO (August 1, 2012)
  • K110386 — CELOX RAPID GAUZE (May 10, 2011)
  • K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TR (December 8, 2010)
  • K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (January 14, 2010)
  • K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (November 20, 2009)
  • K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (November 20, 2009)
  • K080097 — MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET (July 9, 2008)

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