IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER— 510(k) K112549

Name: FDA 510(k) clearance K112549
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Substantially Equivalent

Covalontechnologies, Inc.

FDA 510(k) clearance K112549 for IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER, Substantially Equivalent on 2012-05-04. Applicant: Covalontechnologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Covalontechnologies, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-09-01
Decision date: 2012-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

view all

K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Covalontechnologies, Inc.

view all

K163556 — MediClear PreOp2017-09-14
K150550 — SilverCoat Silicone Foley Catheter2015-11-24
K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER2012-08-13
K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING2005-06-06
K050177 — COLACTIVE COLLAGEN WOUND DRESSING2005-04-27

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.