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510(k) K112549

IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER by Covalontechnologies, Inc. — Product Code FRO

K112549 is an FDA 510(k) premarket notification submitted by Covalontechnologies, Inc. for the device "IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER". The FDA issued a decision of Substantially Equivalent on May 4, 2012. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Covalontechnologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
September 1, 2011
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 Covalontechnologies, Inc.

  • K163556 — MediClear PreOp (September 14, 2017)
  • K150550 — SilverCoat Silicone Foley Catheter (November 24, 2015)
  • K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND (August 13, 2012)
  • K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING (June 6, 2005)
  • K050177 — COLACTIVE COLLAGEN WOUND DRESSING (April 27, 2005)

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