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

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..

Clearance details

Applicant: Exciton Technologies, Inc.
Product code: Code FRO
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 ↗

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.