KerraContact Ag Perf Advanced Perforated Silver Wound Dressing— 510(k) K182680

Name: FDA 510(k) clearance K182680
Creator: U.S. Food and Drug Administration
Published: 2018-12-06

Substantially Equivalent

Exciton Technologies, Inc.

FDA 510(k) clearance K182680 for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing, Substantially Equivalent on 2018-12-06. Applicant: Exciton Technologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Exciton Technologies, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-09-26
Decision date: 2018-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

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K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Exciton Technologies, Inc.

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K162508 — KerraCel Ag Gelling Fiber Silver Dressing2017-02-13
K133775 — EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING2014-03-26
K113564 — EXSALT T7 WOUND DRESSING2011-12-15
K103067 — EXSALT SD7 WOUND DRESSING2011-05-20
K100580 — EXSALT WOUND DRESSING2010-10-12

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.